Solon

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 5, 2024 LMG Lasers Comercio, Importacao e Exportacao Ltda % Rodrigo Abreu Regulatory Specialist United Regulatory Inc 12343 NW 25th St Coral Springs, Florida 33065 Re: K221766 Trade/Device Name: Solon 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: December 6, 2023 Received: December 6, 2023 Dear Rodrigo Abreu: 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. {1}------------------------------------------------ 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" (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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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. 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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). Sincerely, Jianting Wang - S Digitally signed by Jianting Wang -S Date: 2024.01.05 11:17:37 -05'00' For Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical {2}------------------------------------------------ and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221766 Device Name Solon Indications for Use (Describe) Solon is intended to be use in dermatology, cosmetic surgery, and other surgical applications according to the different handpieces. The specific indications should reference to the indications of each handpiece. 1) Pro handpiece: · Incision, excision, ablation, vaporization of soft tissue - · The non-ablative treatment of facial wrinkles - 2) Multistation Handpiece: · Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 3) Vektra QS Handpiece: - · Tattoo Removal: Dark Ink: (Black & Blue) - · Nevus of Ota - · Skin resurfacing procedures for the treatment of acne scars and wrinkles 4) IPL Handpiece: The Intense Pulsed Light wavelengths are 515-1200 nm - · Multiwave: 650-1200 nm The removal of unwanted hair from skin types I-V, and to effect stable long-term, or permanent hair reduction in skin types I - V through selective targeting of melanin in hair follicules. - · Expert Light: 570- 1200nm The treatment of benign pigment (epidermal and cutaneous) lesions, such as warts. - · Expert Light: 515-1200nm The treatment of benign vascular lesions including port wine stains, hemangiomas, facial, truncal anf leg telangiectasias, rosacea, melasma, angiomas and spider aglormas, polkilorderma of civatte, leg veins and venous malformations. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) ## 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. 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LMG Lasers Comércio, Importação e Exportação Ltda Rua Sebastião Monteiro Ferraz № 421 – Polo Industrial Guaxupé, MG Brazil CEP: 37800-000 Tel.: +55 (35) 3559 2500 ### 510(k) SUMMARY K221766 - A) Submitter's Name: LMG Lasers Comércio, Importação e Exportação Ltda Owner / Operator Registration Number: 10059503 Manufacturer Registration Number: Not available yet. Address: Rua Sebastião Monteiro Ferraz Nº 421 - Polo Industrial Guaxupé / MG CEP: 37800-000 #### B) Phone and Fax Numbers Phone: +55 (35) 3559 2499 Fax: (305) 393-8429 - C) Contact Person: Leticia de Paula Souza Moraes - Tel.: +55 (35) 3559 2500 - D) Preparation Date: January 3rd, 2024 - E) Classification Name: Common / Usual Name: Powered laser surgical instrument Proprietary Name: Solon Product Code: GEX Class: Class II Regulation: 21 CFR 878.4810 #### F) Device Description The Solon system is a modular multifunction device. The equipment can be used in dermatology, and aesthetic surgery according to the different handpieces. The Solon system has five laser handpieces of Er:YAG laser, Long Pulse Nd:YAG Laser, and Q-Switch Nd:YAG Laser, and two IPL handpiece. ## G) Substantial Equivalence: The Solon is equivalent with the following products: | 510(k) Number | Model | Company | |---------------|----------------------------|---------------------------------| | K113018 | APOLLO V+ Medical Platform | Beijing Syntech Laser Co., Ltd. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo for Laser Medical Group (LMG). The logo is set against an orange background. The letters "LMG" are in white, bold, sans-serif font. Below the letters, the words "Laser Medical Group" are written in a smaller, white, sans-serif font. ## H) Indications for Use: | Indications for Use Comparison | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Solon | | Solon is intended to be use in dermatology, cosmetic surgery, and other surgical applications according to the different handpieces.<br>The specific indications should reference to the indications of each handpiece. | | 1) Pro handpiece:<br>Incision, excision, ablation, vaporization of soft tissue The non-ablative treatment of facial wrinkles | | 2) Multistation Handpiece:<br>Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. | | 3) Vektra QS Handpiece:<br>Tattoo Removal: Dark Ink: (Black & Blue) Nevus of Ota Skin resurfacing procedures for the treatment of acne scars and wrinkles | | 4) IPL Handpiece:<br>The Intense Pulsed Light wavelengths are 515-1200 nm | | Multiwave: 650-1200 nm<br>The removal of unwanted hair from skin types I-V, and to effect stable long-term, or permanent hair reduction in skin types I - V through selective targeting of melanin in hair follicules. | | Expert Light: 570- 1200nm<br>The treatment of benign pigment (epidermal and cutaneous) lesions, such as warts. | | Expert Light: 515-1200nm<br>The treatment of benign vascular lesions including port wine stains, hemangiomas, facial, truncal anf leg telangiectasias, rosacea, melasma, angiomas and spider aglormas, polkilorderma of civatte, leg veins and venous malformations. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for Laser Medical Group (LMG). The logo is set against an orange background. The letters "LMG" are in white, with a sans-serif font. Below the letters, the words "Laser Medical Group" are written in a smaller, sans-serif font, also in white. ### I) Technological Characteristics Comparison: The predicate devices used to establish substantial equivalence is outlined below. This section of this submission will provide a comparison of dechnical specifications of the Solon to each of the predicate devices stratified by functional modality. | Device Brand and<br>Common Name | Solon | APOLLO V+ Medical Platform | Substantial Equivalence Discussion | |---------------------------------|------------------------------------------------|------------------------------------------------|------------------------------------| | 510k # | Not assigned yet | K113018 | NA | | Classification | II | II | Identical | | Regulation # | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical | | Product Code | GEX | GEX | Identical | | Classification<br>Name | Powered laser surgical<br>instrument | Powered laser surgical instrument | Identical | | Patient Population | Adult | Adult | Identical | | Prescription Use | YES | YES | Identical | | Environment | Clinic/doctor's office | Clinic/doctor's office | Identical | | Applicable<br>Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-22 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-22 | Identical | | Materials | PVC, rubber, electronic<br>components | PVC, rubber, electronic components | Identical | | | Cytotoxicity | Cytotoxicity | Identical | | Biocompatibility | Sensitization | Sensitization | Identical | | | Irritability | Irritability | | | Device Sterilization | Not required | Not required | Identical | | Device physical<br>design | Image: Device 1 | Image: Device 2 | Similar design | | Power Supply | AC Voltage input: 120 V, 50/60<br>Hz | AC Voltage input: 120 V, 50/60 Hz | Identical | | Max Output Power | 1000VA | 1000VA | Identical | | Probe types | IPL, Lasers | IPL, Lasers | Identical | | Control | Touch screen, footswitch | Touch screen, footswitch | Identical | | Working mode | Interval and pulse | Interval and pulse | Identical | | Operative Panel | Color LCD | Color LCD | Identical | | Contact Cooling | Water cooling and air cooling:<br>0-5°C | Water cooling and air cooling: 0-5°C | Identical | | Dimensions | 442mm x 385mm x 1080mm | 420mm x 410mm x 1140mm | Similar Design | | Laser classification | Class 4 | Class 4 | Identical | | Laser mode | Multimode | Multimode | Identical | | Weight | 54,5Kg | 48 kg | Similar Design | | Handpiece<br>Specification | see the explanation of each<br>handpiece | see the explanation of each<br>handpiece | Identical | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Laser Medical Group (LMG). The logo is set against an orange background. The letters "LMG" are in a bold, sans-serif font, and they are white. Below the letters, the words "Laser Medical Group" are written in a smaller, sans-serif font, also in white. LMG Lasers Comércio, Importação e Exportação Ltda Rua Sebastião Monteiro Ferraz № 421 – Polo Industrial Guaxupé, MG Brazil CEP: 37800-000 Tel.: +55 (35) 3559 2500 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image is a logo for Laser Medical Group (LMG). The logo is set against an orange background. The letters "LMG" are in white, large, and bolded. Below the letters, the words "Laser Medical Group" are written in a smaller, less bolded font. LMG Lasers Comércio, Importação e Exportação Ltda Rua Sebastião Monteiro Ferraz Nº 421 – Polo Industrial Guaxupé, MG Brazil CEP: 37800-000 Tel.: +55 (35) 3559 2500 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Laser Medical Group (LMG). The logo is set against an orange background. The letters "LMG" are displayed in a large, white, sans-serif font. Below the letters, the words "Laser Medical Group" are written in a smaller, white font. LMG Lasers Comércio, Importação e Exportação Ltda Rua Sebastião Monteiro Ferraz № 421 – Polo Industrial Guaxupé, MG Brazil CEP: 37800-000 Tel.: +55 (35) 3559 2500 #### SE Discussion: In accordance with the requirements outlined in the Federal Food, Druq, and Cosmetic Act (FD&C Act) and the Food and Druq Administration (FDA) requlations, this discussion aims to establish equivalence of Solon, a medical device, to its predicate(s). The predicate(s) serve as a reference point for evaluating whether Solon effectiveness concerns and whether it meets the necessary criteria for substantial equivalence. In this discussion, we will provide a comprehensive comparison between Solon and its predicate(s) with a focus on technology characteristics, handpieces, safety standards compliance, and performance parameters. #### Technology Characteristics: Solon and its predicate(s) share striking in technology characteristics. Both devices are designed for similar and serve identical functions within the medical field. The key technology parameters, such as energy density, beam divergence, and other energy-related parameters, are closely and its predicate(s). This similarity in technology characteristics underscores the potential for substantial equivalence. #### Handpieces: The handpieces used with Solon and its predicate(s) are remarkably similar in design, They are tailored to accommodate the respective devices' energy parameters and application requirements. The physical attributes, and compatibility with the devices are nearly identical. Therefore, it can be established that the handpieces are substantialy to the overall equivalence of Solon to its predicate(s). ### Safety Standards Compliance: Both Solon and its predicate(s) adhere rigorously to established safety standards and requlations mandated by the FDA and other relevant authorities. These standards include but are not limited to those qoverning electromagnetic compatibility, and user safety, The manufacturers have demonstrated their commitment to ensuring the safety of patients and operators alike. As a result, Solon is in substantial compliance with safety standards, mirroring the predicate(s) in this regard. #### Performance Parameters: The performance parameters of Solon close of its predicate(s). Comprehensive testing and evaluation have demonstrated that Solon operates within the specified performance criteria and meets or exceeds the standards set by the device consistently delivers the desired energy output, spot sizes, energy density, and beam divergence parameters as intended . This consistency in performance parameters reinforces the argument for substantial equivalence. #### Conclusion : In summary, the comparison presented above highlights that Solon achieves to the predicate(s) without raising any safety or effectiveness concerns. The technology characteristics, handards compliance, and performance parameters align closely between Solon and its predicate(s). This alignity for substantial equivalence, paving the way for its evaluation and potential approval by the FDA for its intended medical The substantial equivalence of Solon to the it can provide patients with access to safe and effective heathcare providers and the broader medical community. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image is a logo for Laser Medical Group (LMG). The logo is set against an orange background. The letters "LMG" are in a large, bold, white font. Below the letters, the words "Laser Medical Group" are written in a smaller, white font. LMG Lasers Comércio, Importação e Exportação Ltda Rua Sebastião Monteiro Ferraz № 421 – Polo Industrial Guaxupé, MG Brazil CEP: 37800-000 Tel.: +55 (35) 3559 2500 ## J) Performance and Safety Evaluation: In order to reach high performance, safety and effectiveness the device Solon was developed, as well produced in compliance with recognized international regulations and standards for the medical device industry. | Description | Standard<br>Number | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------| | Medical electrical equipment - Part 1: General requirements<br>for basic safety and essential performance | IEC 60601-1:2005<br>+CORR.1:2006<br>+CORR.2:2007+A1:2012 | | Medical electrical equipment - Part 1-2: General requirements<br>for basic safety and essential performance - Collateral<br>Standard: Electromagnetic disturbances - Requirements and<br>tests | IEC 60601-1-2<br>Edition 4.1<br>2020-09 | | Medical electrical equipment - Part 2-22: Particular<br>requirements for basic safety and essential performance of<br>surgical, cosmetic, therapeutic and diagnostic laser<br>equipment | IEC 60601-2-22<br>Edition 3.1<br>2012-10 | | Biological evaluation of medical devices - Part 1: Evaluation<br>and testing within a risk management process | ISO 10993-1:<br>2018 | | Biological Evaluation of Medical Devices - Tests for In vitro<br>Cytotoxicity. | ISO 10993-5:<br>2009/(R)2014 | | Biological Evaluation of Medical Device - Tests for Irritation<br>and Skin Sensitization. | ISO 10993-10:<br>2010/(R)2014 | ## K) Non-clinical Testing: No clinical trial was performed. ## L) Conclusion: Based on compliance with the international standard and regulation mentioned above, the device Solon demonstrate safety, effectiveness and equivalent to the predicates above.