Diode Laser Therapy System

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 10, 2026 Sanhe LEFIS Electronics Co., Ltd. Dandan Wang Registered Manager Bldg. 11 #1-101, Phase 1 Zhongnan High Tech Yanjiao Science And Technology Innovation Langfang, Hebei 065201 China Re: K261562 Trade/Device Name: Diode Laser Therapy System 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: May 8, 2026 Received: May 11, 2026 Dear Dandan Wang: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261562 - Dandan Wang Page 2 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 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. {2} K261562 - Dandan Wang Page 3 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). Sincerely, # TANISHA L. HITHE -S Digitally signed by TANISHA L. HITHE -S Date: 2026.09.10 14:02:54 -04'00' 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) K261562 Device Name Diode Laser Therapy System Indications for Use (Describe) The Diode Laser Therapy System is intended for hair removal. 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 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} ## 510(k) Summary – K261562 This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of Title 21, CFR Section 807.92. 1. Date of Submission: 2026/9/9 2. Sponsor Identification **Sanhe LEFIS Electronics Co., Ltd.** Building 11 #1-101, Phase 1, Zhongnan High tech, Yanjiao Science and Technology Innovation Smart Valley Industrial Park 1, South Side of Liushan Street and West Side of Gushan West Road, Yanjiao High tech Zone, Sanhe City, 065201 Langfang City, Hebei Province, China Contact Person: Dandan Wang Position: Registered Manager Tel: +86-18131561031 Email: 597782121@qq.com 3. Designated Submission Correspondent Ms. Dandan Wang Tel: +86-18131561031 Fax: +86-316-3096027 Email: 597782121@qq.com 4. Identification of Proposed Device Trade Name: Diode Laser Therapy System Classification Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Information Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Classification: II Product Code: GEX Regulation Number: 21CFR 878.4810 Review Panel: General & Plastic Surgery 5. Indication For Use Statement: The Diode Laser Therapy System is intended for hair removal. {5} 6. Identification of Predicate Device(s) Legally Marketed Predicate Device 510k number: K180719 Trade Name: InMode Diolaze XL System Common Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Classification: II Product Code: GEX Regulation Number: 21 CFR 878.4810 Reference Device 1 510k number: K192569 Manufacturer: Sanhe LEFIS Electronics Co., Ltd. Trade Name: Diode Laser Therapy System Common Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Classification: II Product Code: GEX Regulation Number: 21 CFR 878.4810 Reference Device 2 510k number: K140009 Manufacturer: Alma Lasers Ltd Trade Name: The Modified Alma Lasers XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL Soprano XL and Soprano ICE] Common Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Classification: II Product Code: GEX Regulation Number: 21 CFR 878.4810 7. Environment of Use healthcare facility/hospital 8. Device Description The Diode Laser Therapy System system consists of the following major components: 1. The main console unit incorporates the control panel, power supply modules, cooling system, and service panel. 2. Modules (with umbilical cable and connector) that incorporates the optical head, tissue cooling system (the cold plate) and the trigger. 3. Foot-switch 9. Non-Clinical Test Conclusion Nonclinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: {6} - ANSI/AAMI ES60601-1:2005, ES60601-1:2005/AMD1:2012, ES60601-1:2005/AMD2:2021 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - IEC 60601-1-2 Edition 4.1 2020-09, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - IEC/TR 60601-4-2:2016 Medical electrical equipment - Part 4.2: Guidance and interpretation - electromagnetic immunity: performance of medical electrical equipment and medical electrical systems - IEC 60601-2-22:2019 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment - IEC 60825-1: 2014 Safety of laser products - Part 1: Equipment classification and requirements The body-contacting components of this device are the treatment head. The biocompatibility evaluation for Diode Laser Therapy System was conducted in accordance with the FDA guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process’”. The treatment head is considered skin and subcutaneous tissue contacting for a duration of less than 24 hours. The biocompatible testing included In Vitro Cytotoxicity, Skin Sensitization and Intracutaneous Reactivity was conducted in compliance with: - ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity - ISO 10993- 10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization. - ISO 10993-23:2021 Biological evaluation of medical devices — Part 23: Tests for irritation. We have also conducted: - Software verification and validation test according to the requirements of the FDA “Content of Premarket Submissions for Device Software Functions”. The software for this device was considered as “Basic” Documentation level. Software validation demonstrated that the software functions as specified in the software requirement specifications. - Bench performance testing to show that the device delivers set energy parameters within specifications. #### Sterilization and Shelf-Life The proposed device is not provided sterile and does not need to be sterilized. The handpiece and the body are cleaned with a soft cloth moistened with isopropyl alcohol or ethanol of 75% strength or higher. The proposed device is reusable and does not have a restricted shelf-life. 10. Technological characteristics and substantial equivalence: {7} Table 1 General Comparison | Item | Proposed Device | Primary Predicate Device – K180719 | Reference Device 1 – K192569 | Reference Device 2 – K140009 | Remark | | --- | --- | --- | --- | --- | --- | | Device Name | Diode Laser Therapy System | InMode Diolaze XL System | Diode Laser Therapy System | The Modified Alma Lasers XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL Soprano XL and Soprano ICE] | See Discussion 1 | | Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | SE | | Class | Class II | Class II | Class II | Class II | SE | | Product Code | GEX | GEX | GEX | GEX | SE | | 510K Number | K261562 | K180719 | K192569 | K140009 | / | | Classification Name | Laser Instrument, Surgical, Powered | Laser Instrument, Surgical, Powered | Laser Instrument, Surgical, Powered | Laser Instrument, Surgical, Powered | SE | | Panel | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | SE | | Indications for Use | The Diode Laser Therapy System is intended for hair removal. | The InMode Diolaze XL System with the Diolaze XL 810nm Hand piece is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction | The Diode Laser Therapy System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is | The indications for use for the 810nm Modified Diode Laser Module 2 cm² include: The Hair Removal (HR) and Super Hair Removal(SHR) Mode is intended for permanent reduction in hair regrowth, defined as a long | SE | {8} | | | is hair counts at 6, 9 or 12 months following a treatment regimen. The InMode Diolaze XL System with the Diolaze XL 755/810nm & 810/1064nm Hand pieces is intended for hair removal. | defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. | term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes) The indications for use for the 755nm Diode Laser Module include: The Hair Removal (HR) and Super Hair Removal(SHR) Mode is intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. The treatment of benign vascular and pigmented lesions.(The Laser Blanch Mode) Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR and Laser Blanch Modes) | | | --- | --- | --- | --- | --- | --- | {9} Table 2 Performance Comparison | Item | Proposed Device | Primary Predicate Device – K180719 | Reference Device 1 – K192569 | Reference Device 2 – K140009 | Remark | | --- | --- | --- | --- | --- | --- | | Laser Type | GaAlAs Diode Laser array | GaAlAs Diode Laser array | GaAlAs Diode Laser array | GaAlAs Diode Laser array | SE | | Laser Classification | Class IV | Class IV | Class IV | Class IV | SE | | Laser Wavelength | 2D Wavelength 755nm + 810nm simultaneous | 810 nm 810/1064 nm 755/810 nm | 808nm | 810nm, 755nm | SE | | Spot size | 10 × 20 mm (2 cm²) | 11x 27.5 mm (3.025 cm²) | 2.80cm2 | 810nm: 2cm², 755nm: 2cm² | See Discussion 2 | | Pulse width | 9~150 ms Smooth: 9ms-40ms Stamping: Thick:65ms ; Thin:150ms | 5-200 ms | 3ms-400ms | 3.3ms-200ms | See Discussion 3 | | Energy fluence | 5-40 J/cm2 Smooth:5-20 J/cm2 Stamping: Thick: 5-30 J/cm2 Thin: 5-40 J/cm2 | 5-40 J/cm2 | 2-40 J/cm2 | 810nm: up to 60 J/cm2, 755nm: up to 120 J/cm2, | See Discussion 3 | | Pulse frequency | 0.5,1,2,3,5,10Hz Smooth: 3Hz,5Hz,10Hz Stamping: | 1, 2Hz | 1~10Hz | 0.5-3,5-10 | See Discussion 4 | {10} | Item | Proposed Device | Primary Predicate Device – K180719 | Reference Device 1 – K192569 | Reference Device 2– K140009 | Remark | | --- | --- | --- | --- | --- | --- | | | Thick: 0.5Hz,1Hz Thin: 0.5Hz,1Hz,2Hz,3Hz | | | | | | Cooling System | Sapphire contact cooling | Sapphire contact cooling | Sapphire contact cooling | Sapphire contact cooling | SE | | User interface | 10.4" color touch LCD screen | LCD touch screen | 12" color touch LCD screen | 12" LCD touch screen | SE | {11} Table 3 Safety Comparison | Item | Proposed Device | Primary Predicate Device – K180719 | Reference Device 1 – K192569 | Reference Device 2 – K140009 | Remark | | --- | --- | --- | --- | --- | --- | | Electrical Safety | Comply with ANSI/AAMA ES 60601-1, IEC 60601-2-22 | Comply with ANSI/AAMA ES 60601-1, IEC 60601-2-22 | Comply with ANSI/AAMA ES 60601-1, IEC 60601-2-22 | Comply with ANSI/AAMA ES 60601-1, IEC 60601-2-22 | SE | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE | | Laser Safety | Comply with IEC 60601-2-22, IEC 60825-1 | Comply with IEC 60601-2-22, IEC 60825-1 | Comply with IEC 60601-2-22, IEC 60825-1 | Comply with IEC 60601-2-22, IEC 60825-1 | SE | | Biocompatibility | Comply with ISO 10993-5:2009 Comply with ISO 10993-10:2021 Comply with ISO 10993-23:2021 | Comply with ISO 10993-5:2009 Comply with ISO 10993-10:2021 Comply with ISO 10993-23:2021 | Comply with ISO 10993-5:2009 Comply with ISO 10993-10:2021 Comply with ISO 10993-23:2021 | Compliant with ISO 10993 series requirements | SE | {12} ## Discussion 1 – The difference of name The naming difference does not affect safety, effectiveness or the substantial equivalence determination. ## Discussion 2 – Spot Size The proposed semiconductor laser hair removal device has a treatment spot size of 10 × 20 mm (2 cm²), compared to the predicate device K180719 with a spot size of 11 × 27.5 mm (3.025 cm²). The intended use of the proposed device is identical to the predicate: laser hair removal via selective photothermolysis targeting melanin within hair follicles. The maximum allowable energy fluence of the proposed device matches the predicate. Therefore, this difference does not negatively impact safety or effectiveness. ## Discussion 3 –Pulse Width and Energy Fluence The pulse width adjustable range of the proposed device is 9–150 ms, which is fully contained within the validated 5–200 ms range of predicate K180719, representing more conservative operating limits for laser hair removal. The overall adjustable energy fluence range is 5–40 J/cm², identical to the predicate. The differences have no adverse impact on safety and effectiveness for laser hair removal. ## Discussion 4 – Pulse Frequency The proposed device supports a maximum pulse frequency of 10 Hz, which is higher than primary predicate K180719 (max 2 Hz). The 3, 5, 10 Hz high-frequency range is firmware-locked exclusively to Smooth mode. Within Smooth mode, firmware hard-limits each wavelength-channel fluence to 5-20 J/cm². high-fluence parameters (>20 J/cm²) are programmatically disabled when frequency exceeds 3, 5 Hz. In practical clinical use, simultaneous maximum 20 J/cm² for both 755 nm and 810 nm channels at 10 Hz is not an intended routine clinical setting for Smooth mode. Reference device K192569 (single 808 nm) provides precedent for 1-10 Hz high-frequency hardware implementation and safety interlock philosophy for hair-removal laser systems. Reference device K140009 supports 5-10 Hz at fluence up to 20 J/cm² for individually-selected 755 nm or 810 nm wavelength; Even though Smooth mode enables simultaneous 755 nm + 810 nm irradiation, each individual channel fluence cannot exceed 20 J/cm², consistent with the validated high-frequency fluence upper boundary established by K140009. The 755 nm and 810 nm wavelengths have distinct skin penetration and absorption profiles: 755 nm deposits relatively more thermal energy in the superficial dermis, while 810 nm penetrates deeper. Their thermal depositions do not fully superimpose within identical skin tissue layers. The device-integrated contact cooling continuously lowers epidermal temperature during treatment. Combined with multi-layer firmware safeguards to bind high frequency to low-moderate fluence window, potential thermal-accumulation risk under simultaneous dual-wavelength high-frequency operation is adequately mitigated. No new or increased thermal-injury hazards are introduced compared with the primary predicate. In summary, the differences in pulse frequency are fully controlled by firmware mode-lock, parameter hard-limitation, contact cooling, and proven safety precedents from cleared predicate and reference devices. The proposed device is substantially equivalent to primary predicate K180719 with respect to these performance parameters. {13} 11. Clinical Test Conclusion No clinical study is included in this submission. 12. Substantially Equivalent (SE) Conclusion Based on the performance testing and comparison to predicate and reference devices, the Diode Laser Therapy System is as safe and effective as its predicate/reference devices and is substantially equivalent to the predicate device.