← Product Code [GEX](/productcode/GEX) · K252723 # Dynamis Pro Family (K252723) _Fotona D.O.O. · GEX · Sep 19, 2026 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K252723 ## Device Facts - **Applicant:** Fotona D.O.O. - **Product Code:** [GEX](/productcode/GEX.md) - **Decision Date:** Sep 19, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic, Real-World Evidence ## Real-World Evidence | Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags | | --- | --- | --- | --- | --- | --- | | K252723 · Sep 19, 2026 | Dynamis Pro Family | Fotona D.O.O. | Retrospective multicenter European clinical study | The retrospective study was used to provide additional evidence supporting clinically visible improvements and a low risk profile for the device when used under routine clinical conditions. | Retrospective study; Multicenter; Routine clinical use; Hair loss | ### Clinical Evidence | Study Design | Population | Comparator | Key Endpoints | | --- | --- | --- | --- | | Retrospective multicenter European study; Retrospective multicenter study | Subjects seeking treatment for hair loss; Number of Sites: Multicenter | Not applicable for this study | Clinically visible improvements in hair appearance; safety profile | ## Indications for Use Er:YAG laser (2940 nm wavelength): The Dynamis Er:YAG laser is intended for surgical incision/excision, cutting ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. - Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing; - Soft tissue resurfacing with S22 and S22-T scanner; - ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia; - Oral/Maxillofacial Indications: Oral and glossal lesions; - Uvulopalatoplasty by laser resurfacing - Ophthalmology Indications: Soft tissue surrounding the eye; - Intra-oral soft tissue incision, excision, ablation, coagulation - General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation is necessary; - Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma; - Genitourinary Indications: lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon; - Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy; - The Fotona F-22 Handpiece is intended for: • In fractionated mode: - Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece; • In non-fractionated mode: - General Surgery Indications: - Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation is necessary; - The Fotona FS-01 and X-Restart Handpieces are intended for: - Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece; - The Dynamis Family Er:YAG laser is indicated for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss. Nd:YAG laser (1064 nm wavelength): The Dynamis Nd:YAG laser is intended for incision, ablation, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological and surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI. - Surgical incision, excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal, frenectomy and frenotomy; - Treatment of Aphthous Ulcers; - Excision and Vaporization of Herpex Simplex I and II; - Laser assisted uvulopalatoplasty (LAUP); - Laser assisted lipolysis; - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime; - Treatment of wrinkles; - Treatment of wrinkles with S11 scanner; - Treatment of mild to moderate inflammatory acne vulgaris; - Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins; - Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - Matrixectomy - Radical nail excision - Periungual and subungual warts - Plantar warts - Neuromas - Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) - Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities. Nd:YAG laser (1064 nm wavelength) therapy: - Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle. ## Device Story Dynamis Pro Family is a multi-wavelength laser system (Er:YAG 2940 nm and Nd:YAG 1064 nm) housed in a single console. System uses flashlamp-pumped crystals to generate therapeutic beams, combined with a 650 nm red diode aiming beam. Energy delivered via articulated arm or optical fiber to manual or scanner handpieces. Operated by professionals in clinical settings. Er:YAG mode performs tissue ablation/resurfacing; Nd:YAG mode performs coagulation, hemostasis, and hair reduction. New indication for hair loss improvement utilizes non-ablative SMOOTH mode to induce thermal effects in scalp tissue. Output is controlled by the clinician to achieve specific thermal tissue responses. Benefits include precise tissue management, hair growth improvement, and pain relief. ## Clinical Evidence Clinical evidence includes a prospective cohort study (32 AGA subjects), a U.S. study (16 AGA subjects), a European study (24 subjects), and a pilot feasibility study (10 AGA subjects). Results demonstrate improved hair appearance and increased hair density. Retrospective multicenter European study confirms clinical improvements and low risk profile. No serious adverse effects reported. ## Technological Characteristics Dual-wavelength solid-state laser (Er:YAG 2940 nm, Nd:YAG 1064 nm); flashlamp-pumped; articulated arm or fiber delivery; red diode aiming beam (650 nm); PS03X scanner handpiece; electrical power source; complies with IEC 60601-1 and IEC 60601-1-2. ## Regulatory Identification (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon. ## Predicate Devices - F65 Laser System ([K222790](/device/K222790.md)) - Dynamis Pro Family ([K213267](/device/K213267.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **U.S. FOOD & DRUG** ADMINISTRATION September 19, 2026 Fotona d.o.o. Tina Bartolic Quality Assurance and Regulatory Affairs Specialist Stegne 7 Ljubljana, Slovenia Re: K252723 Trade/Device Name: Dynamis Pro Family Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: September 14, 2026 Received: September 14, 2026 Dear Tina Bartolic: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K252723 - Tina Bartolic Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2} K252723 - Tina Bartolic Page 3 Sincerely, YAN FU -S Digitally signed by YAN FU -S Date: 2026.09.19 01:13:40 -04'00' for Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K252723 Device Name Dynamis Pro Family Indications for Use (Describe) Er:YAG laser (2940 nm wavelength): The Dynamis Er:YAG laser is intended for surgical incision/excision, cutting ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. - Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing; - Soft tissue resurfacing with S22 and S22-T scanner; - ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia; - Oral/Maxillofacial Indications: Oral and glossal lesions; - Uvulopalatoplasty by laser resurfacing - Ophthalmology Indications: Soft tissue surrounding the eye; - Intra-oral soft tissue incision, excision, ablation, coagulation - General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation is necessary; - Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma; - Genitourinary Indications: lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon; - Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy; - The Fotona F-22 Handpiece is intended for: • In fractionated mode: - Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece; • In non-fractionated mode: - General Surgery Indications: - Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation is necessary; - The Fotona FS-01 and X-Restart Handpieces are intended for: - Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece; - The Dynamis Family Er:YAG laser is indicated for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss. Nd:YAG laser (1064 nm wavelength): The Dynamis Nd:YAG laser is intended for incision, ablation, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological and surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI. - Surgical incision, excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, striated and FORM FDA 3881 (8/23) Page 1 of 2 PSC Publishing Services (301) 443-6740 EF {4} smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal, frenectomy and frenotomy; - Treatment of Aphthous Ulcers; - Excision and Vaporization of Herpex Simplex I and II; - Laser assisted uvulopalatoplasty (LAUP); - Laser assisted lipolysis; - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime; - Treatment of wrinkles; - Treatment of wrinkles with S11 scanner; - Treatment of mild to moderate inflammatory acne vulgaris; - Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins; - Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - Matrixectomy - Radical nail excision - Periungual and subungual warts - Plantar warts - Neuromas - Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) - Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities. Nd:YAG laser (1064 nm wavelength) therapy: - Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (8/23) Page 2 of 2 PSC Publishing Services (301) 445-6740 EF {5} # **510(K) SUMMARY K252723** | **1. SUBMITTER INFORMATION** | | | --- | --- | | Applicant & Official Correspondent | Ms. Tina Bartolic Quality Assurance and Regulatory Affairs Specialist Fotona d.o.o. Stegne 7, Ljubljana, Slovenia +38615009100 tina.bartolic@fotona.com | | Date Prepared | September 17, 2026 | | **2. DEVICE NAME** | | | Trade Name of the Device | Dynamis Pro Family | | Models | M021-4AF/3, M001-12F, M002-2A | | Common Name: | Dynamis Pro Family | | Classification Name: | Powered Laser Surgical Instrument | | Classification Regulation: | 878.4810 | | Device Class: | II | | Product Code: | GEX | | Panel: | General and Plastic Surgery | | **3. PREDICATE DEVICE IDENTIFICATION** | K222790 F65 Laser System K213267 Dynamis Pro Family | | **4. DEVICE DESCRIPTION:** | The Dynamis Pro Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er:YAG and Nd:YAG crystals. A red diode aiming beam (650 nm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical manual or scanner handpiece (in the case of the Er:YAG laser), or through an optical fiber delivery system to an optical manual or scanner handpiece (in the case of the Nd:YAG laser). Optionally, the Nd:YAG therapeutic and aiming laser beams can be guided through a fiber having a connector on the proximal end and a bare fiber on the distal end. The Dynamis Pro Family is designed to operate in single wavelength (Nd:YAG or Er:YAG) configurations (models) and dual wavelength (Nd:YAG and Er:YAG) configurations (models). | Page 1 of 6 {6} | 5. INDICATIONS FOR USE: | Er:YAG laser (2940 nm wavelength): The Dynamis Er:YAG laser is intended for surgical incision/excision, cutting ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. - Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing; - Soft tissue resurfacing with S22 and S22-T scanner; - ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia; - Oral/Maxillofacial Indications: Oral and glossal lesions; - Uvulopalatoplasty by laser resurfacing - Ophthalmology Indications: Soft tissue surrounding the eye; - Intra-oral soft tissue incision, excision, ablation, coagulation - General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation is necessary; - Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma; - Genitourinary Indications: lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon; - Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy; - The Fotona F-22 Handpiece is intended for: • In fractionated mode: - Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece; • In non-fractionated mode: - General Surgery Indications: - Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation is necessary; - The Fotona FS-01 and X-Restart Handpieces are intended for: - Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece; - The Dynamis Family Er:YAG laser is indicated for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss. Nd:YAG laser (1064 nm wavelength): The Dynamis Nd:YAG laser is intended for incision, ablation, | | --- | --- | Page 2 of 6 {7} | | vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological and surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI. - Surgical incision, excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal, frenectomy and frenotomy; - Treatment of Aphthous Ulcers; - Excision and Vaporization of Herpex Simplex I and II; - Laser assisted uvulopalatoplasty (LAUP); - Laser assisted lipolysis; - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime; - Treatment of wrinkles; - Treatment of wrinkles with S11 scanner; - Treatment of mild to moderate inflammatory acne vulgaris; - Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins; - Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - Matrixectomy - Radical nail excision - Periungual and subungual warts - Plantar warts - Neuromas - Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) - Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities. Nd:YAG laser (1064 nm wavelength) therapy: - Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle. | | --- | --- | | 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | | Page 3 of 6 {8} | Manufacturer | Lumenis, Ltd | Fotona, d.o.o. | Fotona, d.o.o. | SE determination | | --- | --- | --- | --- | --- | | Device name | F65 Laser System | Dynamis Pro Family | Dynamis Pro Family | | | | Predicate device | Predicate device | Subject device | | | 510 (k) number | K222790 | K213267 | K252723 | | | **Regulation** | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same for subject laser indication | | **Product Code/ Subsequent code** | GEX ONF, ONG | GEX | GEX | | | **Rx or OTC** | Rx | Rx | Rx | | | **Clinic/Home use** | Clinic Use by professional operator | Clinic Use by professional operator | Clinic Use by professional operator | Same | | **Indications for use** | The F65 module and handpiece, with wavelength of 1565 nm, are indicated for: - use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue - improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss. | Soft tissue resurfacing^{(1)} | The Dynamis Family Er:YAG laser is indicated for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss. | Same as predicate device 1. Different clinical outcome but the same mechanism of action and handpiece as the reference device. | | **Device configuration** | System console and handpiece | System console and handpiece | System console and handpiece | Same | | **Wavelength** | 1565 nm | 2940 nm | 2940 nm | Similar in terms of absorbing skin chromophore and resulting thermal effects.^{(2)} The difference in wavelength does not result in clinically meaningful differences in safety or effectiveness.^{(3)} | | **Type of laser** | Er:Glass laser | Er:YAG laser | Er:YAG laser | N/A. Different solid state laser material. | | **Principle of action** | Non-ablative skin heating | Non-ablative skin heating | Non-ablative skin heating | Same. | | **Handpiece** | 1565 nm scanning module with adjustable number of up to 500 micro-beams/cm^{2}. Micro-beam size: 0.25 mm | PS03X with fixed number of 40 micro-beams/cm^{2} Micro-beam size: 0.9 mm | PS03X with fixed number of 40 micro-beams/cm^{2} Micro-beam size: 0.9 mm | Similar.^{(4)} Differences in spot size are mitigated through parameter selection.^{(5)} The difference in spotsize does not result in clinically meaningful differences in safety or effectiveness.^{(2)} | | **Skin coverage** | Up to 25 % | 30 % | 30 % | Similar. | Page 4 of 6 {9} | Laser pulse energy and fluence per micro-beam | Energy: up to 70 mJ Fluence: up to 140 J/cm² | Energy: 23-152 mJ* Fluence: 3.6 – 24 J/cm² *SMOOTH mode | Energy: 45-64 mJ* Fluence: 7 – 10 J/cm² *SMOOTH mode | Similar. The difference in fluence does not result in clinically meaningful differences in safety or effectiveness.(5) | | --- | --- | --- | --- | --- | | (1) For the list of all previously cleared indications for Dynamis Pro Family see K213267 (2) Fotona Thermal Safety Report– Laser Stimulation of Hair Growth (#01/2026). Substantial equivalence based on FDA Guidance “Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling” (2024) and FDA Guidance “Credibility of Computational Modeling and Simulation in Medical Device Submissions” (2023) (3) Although the devices differ in wavelength, the difference is offset by adjustments in energy delivery and exposure duration, resulting in comparable thermally affected tissue depth and Arrhenius damage. This is because the duration of SMOOTH pulse 2940 nm energy delivery and resulting depth of thermal diffusion compensates for the deeper optical penetration depth of 1565 nm. See Fotona Thermal Safety Report.(1) (4) Fotona PS03X handpiece has been cleared also for dermatological indications: soft tissue resurfacing, epidermal nevi, actinic cheilitis, verrucae, skin tags and keratoses (K213267). Lumenis 1565 nm handpiece has been cleared also for dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue (K193500). (5) The subject device operates at lower fluence, larger spot size, and longer pulse duration, resulting in a lower tissue temperature increase that persists longer, whereas the predicate operates at higher fluence, smaller spot size, and shorter pulse duration, producing a higher tissue temperature increase that persists shorter. | | The new indication for the Fotona Dynamis laser system family (2940 nm): “Improving the appearance of scalp hair in adult males and females with Fitzpatrick skin types I to IV who are seeking treatment for hair loss” is the same as that of the predicate device, the Lumenis F65 Laser Module System (1565 nm), K222790. The new indication for Fotona Dynamis laser system family (2940 nm) does not raise different questions of safety or effectiveness and is adequately supported by the validation testing. The conclusions drawn from the thermal bench testing and clinical testing, and substantial equivalence comparison with predicate device demonstrate that the subject device is as safe, as effective, and performs as well as the predicate Lumenis F65 laser module system laser, K222790, (1565 nm). Thus, Fotona Dynamis laser system family (2940 nm) is substantially equivalent to Lumenis F65 laser module system laser (1565 nm), for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss. | | 7.SUMMARY OF NONCLINICAL TESTING: | Below is a list of the tests that were performed and successfully completed for the subject device per the specified guidance and standards: • Electrical Safety testing, mechanical strength testing and thermal safety testing according to IEC 60601-1:2025+AMD1:2012+AMD2:2020 - Medical electrical equipment –Basic safety and essential performance. • Electromagnetic Compatibility testing according to IEC 60601-1-2:2014+AMD1:2020– General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests. • Software Verification and Validation Testing according to FDA’s Guidance (2023),“Content of Premarket Submissions for Device Software Functions | FDA” • Cybersecurity testing according to FDA Guidance document (2026), “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket | Page 5 of 6 {10} | | Submissions | FDA All pre-determined acceptance criteria were met. | | --- | --- | --- | | **8. SUMMARY OF CLINICAL TESTING:** | Clinical performance data was provided for the Fotona Dynamis Er:YAG laser with non-ablative SMOOTH mode used in adults seeking treatment for hair loss. The sponsor provided primary clinical support via a prospective clinical cohort study (based in China) of 32 AGA subjects, a small clinical study in the U.S. which included 16 AGA subjects (6 laser only effectiveness subjects), and a clinical study conducted in Europe that included 24 treated subjects (12 laser-only effectiveness subjects.) Supportive clinical data was provided via a pilot feasibility and safety study (10 AGA subjects) that included trichoscopy. Overall, the results show improvement in hair appearance and increased hair density. Furthermore, a retrospective multicenter European study based on real-world clinical data provides additional evidence supporting clinically visible improvements and low risk profile under routine clinical-use conditions. No serious adverse effects were observed in the studies provided. | | **9. CONCLUSIONS** | Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to predicate devices. | Page 6 of 6 --- **Source:** [https://fda-staging.innolitics.com/device/K252723](https://fda-staging.innolitics.com/device/K252723) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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