← Product Code [GEX](/productcode/GEX) · K262070 # Diode Laser Therapy Systems (DL612A) (K262070) _Hebei Zollvan Medical Technology Co., Ltd. · GEX · Aug 19, 2026 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K262070 ## Device Facts - **Applicant:** Hebei Zollvan Medical Technology Co., Ltd. - **Product Code:** [GEX](/productcode/GEX.md) - **Decision Date:** Aug 19, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The Diode Laser Therapy Systems (DL612A) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is 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. ## Device Story Diode laser system (808 nm) for hair removal; consists of main unit (power supply, controller, cooling system, display) and handpiece. Microprocessor-controlled laser module converts electrical energy to constant current, producing continuous 808 nm laser output. Laser beam directed through light guide crystal to skin; light energy absorbed by hair follicles, converted to heat, destroying follicle tissue to prevent regeneration. Used in clinical settings by trained professionals. Output parameters (fluence, pulse duration, frequency) adjusted via system interface. Benefits include permanent hair reduction. Safety features include emergency stop and foot switch. ## Clinical Evidence No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-5, -10, -23), electrical safety (AAMI/ANSI ES60601-1), EMC (IEC 60601-1-2), and laser safety (IEC 60601-2-22, IEC 60825-1). ## Technological Characteristics Diode laser, 808 nm wavelength, Class IV. Fluence: 1-40 J/cm² (FAST) or 1-120 J/cm² (NORMAL). Pulse duration: 10-400 ms. Frequency: 1-10 Hz. Spot size: 2.25 cm². Power: 110-240VAC. Cooling system included. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1. ## 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 - Diode Laser Machine, Model Number: BM-100 ([K211335](/device/K211335.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 August 19, 2026 Hebei Zollvan Medical Technology Co., Ltd. % Liya Meng RA Manager Tianjin Xinnuocheng Medical Technology Co., Ltd. Rm. 1505, Wanhai Bldg., Dazhigu Sub-District Hedong District Tianjin, 300170 China Re: K262070 Trade/Device Name: Diode Laser Therapy Systems (DL612A) 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: June 18, 2026 Received: June 22, 2026 Dear Liya Meng: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262070 - Liya Meng Page 2 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" (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. {2} K262070 - Liya Meng Page 3 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). Sincerely, TANISHA L. HITHE -S Digitally signed by TANISHA L. HITHE -S Date: 2026.08.19 23:14:30 -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) K262070 Device Name Diode Laser Therapy Systems (DL612A) Indications for Use (Describe) The Diode Laser Therapy Systems (DL612A) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is 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. 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 K262070 ## 510(k) Summary 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 Preparation: 2026/07/29 2. Sponsor Identification **Hebei Zollvan Medical Technology Co., Ltd** No.201,3rd Building, Zhidian Industrial Park, No.999 Fuxing East Road, Bailou Town, Lianchi District, Baoding, 071030 Hebei Province, China Contact Person: Zhichao Ma Position: R&D Manager Tel: +86-18612170963 Email: 350987087@qq.com 3. Designated Submission Correspondent Ms. Liya Meng Tianjin Xinnuocheng Medical Technology Co., LTD. Room 1505, Wanhai Building, Dazhigu Sub-district, Hedong District Tianjin, Hedong 300170 CHINA Tel: +86-15620589932 Email: ra@tianjinxinnuochengyi.com.cn 4. Identification of Proposed Device Trade Name: Diode Laser Therapy Systems (DL612A) Common Name: Powered Laser Surgical Instrument Regulatory Information Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Classification: II Product Code: GEX Regulation Number: 878.4810 Review Panel: General & Plastic Surgery 1 / 5 {5} 510(k) Summary K262070 # 5. Identification of Predicate Device(s) Predicate device: 510(k) Number: K211335 Product Name: Diode Laser Machine, Model Number: BM-100 Manufacturer: Zhengzhou Bestview St Co., Ltd. # 6. Device Description The proposed device incorporates a diode laser that emits invisible infrared laser radiation centered on a wavelength of 808 nm. It is mainly composed of main unit (include Power Supply Modules, System Controller, Cooling System and Display module, Emergency stop switch and Foot switch) and handpiece. The working principle of the system: The microprocessor controls the laser power supply to provide the laser module with an adjustable constant current. The high-power laser diode inside the laser module converts electrical energy into light energy, and outputs a continuous laser with a wavelength of 808nm. The laser beam passes through a light guide crystal When irradiated on the tissue to be depilated, it passes through the surface of the skin to reach the hair follicle. The light energy is absorbed and converted into heat energy that destroys the hair follicle tissue, so that the hair falls off and loses the ability to regenerate, achieving the purpose of hair removal. # 7. Indication For Use Statement: The Diode Laser Therapy Systems (DL612A) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is 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. # 8. Substantially Equivalent (SE) Comparison Table 1 General Comparison | Item | Proposed Device Diode Laser Therapy Systems | Predicate Device(K211335) Diode Laser Machine | Remark | | --- | --- | --- | --- | | Classification Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME | | Classification | II | II | SAME | | Product Code | GEX | GEX | SAME | | Regulation Name | Laser surgical instrument for use in general and plastic surgery and in dermatology | Laser surgical instrument for use in general and plastic surgery and in dermatology | SAME | 2 / 5 {6} 510(k) Summary K262070 | Indications for use | The Diode Laser Therapy Systems (DL612A) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is 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. | The Diode Laser Machine (Model: BM-100) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is 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. | SAME | | --- | --- | --- | --- | | Prescription use or not | Prescription use | Prescription use | SAME | Table 2 Performance Comparison | Item | Proposed Device Diode Laser Therapy Systems | Predicate Device(K211335) Diode Laser Machine | Remark | | --- | --- | --- | --- | | Laser Type | Diode Laser | Diode Laser | SAME | | Laser Classification | Class IV | Class IV | SAME | | Laser wavelength | 808 nm | 808 nm | SAME | | Spot Size | 2.25 cm² (10mm x 22.5mm) | 2.25 cm² (15mm x 15mm) | Analysis 1 | | Fluence (Energy Density) | FAST: 1-40J/cm² NORMAL: 1-120J/cm² | 0-120 J/cm2 | Analysis 2 | | Frequency | 1-10 Hz | 1-10 Hz | SAME | | Pulse Duration | 10-400 ms | 10-400 ms | SAME | | Power Supply | 110~240VAC 50/60Hz | 220/110 VAC/50Hz-60Hz | Analysis 3 | # Analysis: # Analysis 1-Spot Size The areas of the spots are the same (both 2.25 cm²).The difference in geometry would not impact the safety and effectiveness, because the final safety and effectiveness depends on the amount of energy output per unit area. 3 / 5 {7} 510(k) Summary K262070 ### Analysis 2-Fluence (Energy Density) The predicate device has a single fluence range of 0–120 J/cm², while the proposed device is split into FAST(1–40 J/cm²) and NORMAL(1–120 J/cm²). The fluence of the proposed device is fully covered within the predicate's fluence range. ### Analysis 3-Power Supply The Power Supply of proposed device is different with the predicate device, but the proposed device has been conducted as IEC 60601-1 and IEC 60601-1-2, the results shown that, there is no effect the effectiveness and safety. ### 9. Non-Clinical Testing Non clinical tests were conducted to verify that the proposed device met all design specifications and to support the Substantial Equivalence determination. ### Biocompatibility testing Testing was conducted to demonstrate that the proposed device complies with the following standards: - ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - ISO 10993-10 Fourth edition 2021-11, Biological evaluation of medical devices - Part 10: Tests for skin sensitization. - ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation ### Electrical safety and electromagnetic compatibility (EMC) Testing was conducted to demonstrate that the proposed device complies with the following standards: - AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - IEC 60601-1-2:2014+A1:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - IEC TS 60601-4-2 Edition 1.0 2024-03 Medical electrical equipment - Part 4-2: Guidance and interpretation- Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems ### Laser Safety Testing was conducted to demonstrate that the proposed device complies with the following standards: - IEC 60601-2-22 Edition 4.0 2019-11, Medical electrical equipment - Part 2-22: Particular 4 / 5 {8} 510(k) Summary K262070 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 # **Software Verification and Validation Testing** Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software documentation level for this device was determined to be "basic." # **Specification Testing** Testing was conducted to validate that the proposed device meets technical specifications for wavelength, fluence, pulse duration, spot size, and frequency. # 10. Clinical Testing No clinical study is included in this submission. # 11. Conclusion The data obtained from the nonclinical tests support that the device is as safe, as effective, and performs as well as the legally marketed predicate device. 5 / 5 --- **Source:** [https://fda-staging.innolitics.com/device/K262070](https://fda-staging.innolitics.com/device/K262070) **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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