← Product Code [GEX](/productcode/GEX) · K260307 # Diode Laser Therapy Systems (V19) (K260307) _Weifang Mingliang Electronics Co., Ltd. · GEX · Apr 15, 2026 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K260307 ## Device Facts - **Applicant:** Weifang Mingliang Electronics Co., Ltd. - **Product Code:** [GEX](/productcode/GEX.md) - **Decision Date:** Apr 15, 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 Diode Laser Therapy Systems is intended to be used for hair removal of patients with hirsutism. It is indicated for use on all skin types (Fitzpatrick Skin Types 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 Therapy Systems (V19) is a console-based laser device for hair removal. Principle: selective photothermal dynamics; 808nm diode laser penetrates skin to reach hair follicles; melanin absorbs laser energy, converting it to heat to destroy follicle function and inhibit regeneration. System includes main unit, handle, and foot control. Operated by clinicians in clinical settings. Parameters (fluence, pulse duration, frequency) controlled via LCD touch-screen interface and micro-controller. Output is 808nm laser energy. Benefits include permanent hair reduction. Device construction uses aluminum alloy and sapphire for patient-contacting components. ## Clinical Evidence No clinical data. Bench testing only, including biocompatibility (ISO 10993-5, -10, -23), electrical safety (IEC 60601-1, -2-22), and electromagnetic compatibility (IEC 60601-1-2). ## Technological Characteristics Class IV diode laser; 808nm wavelength; 12mm x 24mm spot size; 100J/cm² fluence; 1-10Hz frequency; 1-200ms pulse duration. Materials: aluminum alloy, sapphire. Console-based with LCD touch-screen. Power: 110VAC. Sterilization: not specified. Software: basic documentation level. ## 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 therapy system ([K212978](/device/K212978.md)) ## Reference Devices - Elite iQ ([K193426](/device/K193426.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} FDA U.S. FOOD & DRUG ADMINISTRATION April 15, 2026 Weifang Mingliang Electronics Co., Ltd. Mingliang Li General Manager 1-301, Bldg. 15, Phase 1, Yuandu Huizhi Industrial Complex # 3999, Taixiang St., Weifang Economic Development Zone Shan Dong, 261000 China Re: K260307 Trade/Device Name: Diode Laser Therapy Systems (V19) 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 11, 2025 Received: January 30, 2026 Dear Mingliang Li: 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} K260307 - Mingliang Li 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 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and 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 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 (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- {2} K260307 - Mingliang Li Page 3 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: 2026.04.15 08:47:35 -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} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K260307 | | | Device Name Diode Laser Therapy Systems (V19) | | | Indications for Use (Describe) Diode Laser Therapy Systems is intended to be used for hair removal of patients with hirsutism. It is indicated for use on all skin types (Fitzpatrick Skin Types 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." | | {4} 510(k) Summary - K260307 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: 11/12/2025 2. Sponsor Identification Weifang Mingliang Electronics CO., LTD. 1-301, Building 15, Phase 1, Yuandu Huizhi Industrial Complex, No.3999, Taixiang Street, Weifang Economic Development Zone, 261000, Shandong, P.R. China Contact Person: xingzaisheng Position: System Certification Specialist Tel: +86-13406649353 Email: admin@mingliangkj.com 3. Identification of Proposed Device Trade Name: Diode Laser Therapy Systems (V19) Common Name: Powered Laser Surgical Instrument Regulatory Information Classification Name: Powered Laser Surgical Instrument Classification: II Product Code: GEX Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulation Medical Specialty: General & Plastic Surgery Review Panel: General & Plastic Surgery Indication For Use Statement: Diode Laser Therapy Systems is intended to be used for hair removal of patients with hirsutism. It is indicated for use on all skin types (Fitzpatrick Skin Types 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. 4. Device Description The Diode Laser Therapy Systems hair removal is based on the principle of selective photothermal dynamics, because the skin of human body is a relatively transparent structure. The laser can penetrate the skin very smoothly and reach the hair follicle, which is the position of hair growth. The melanin in the hair follicle absorbs a lot of laser energy and finally converts it into heat energy. Make the temperature of hair follicle rise, so as to destroy the function of hair follicle, make hair lose the ability of regeneration, and then play the purpose of depilation. {5} Laser parameters and other system features are controlled from the control panel on the console, which provides an interface to the system's micro-controller through a LCD touch-screen. In the handle of the machine, the light emitted by each discharge contains 808nm wavelengths. ## 5. Identification of Predicate Device(s) Predicate Device 510(k) Number: K212978 Product Name: Diode laser therapy system Manufacturer: BEIJING UNT Technology Co., Ltd. Reference Device 1 510(k) Number: K193426 Product Name: Elite iQ Manufacturer: Cynosure, LLC ## 6. Non-Clinical Test Conclusion Non-clinical testing was conducted to verify that the proposed device met design specifications. The test results demonstrated that the proposed device conforms to the following performance standards: - EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization - EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for irritation - IEC 60601-1:2005 + A1:2012: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Amendment 1 - 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 - IEC 60601-1-2: 2014+A1: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests ## 7. Software Validation & Verification Testing Software verification & 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 for this device was considered as a Basic Documentation level, since a failure or latent flaw in the software could directly result in erroneous diagnosis or a delay in delivery of appropriate medical care, which could result in minor injury. ## 8. Clinical Test Conclusion No clinical study is included in this submission {6} 9. Substantially Equivalent (SE) Comparison | Device Characteristic | Subject Device | Predicate Device (K212978) | Reference Device 1 (K193426) | Discussion | | --- | --- | --- | --- | --- | | Trade name | Diode Laser Therapy Systems | Diode laser therapy system | Elite iQ | N/A | | Product code | GEX | GEX | GEX | Same | | Manufacturer | Weifang Mingliang Electronics CO., LTD. | BEIJING UNT Technology Co., Ltd. | Cynosure, LLC | N/A | | Device Classification | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | Same | | Intended Use | Diode Laser Therapy Systems is intended to be used for hair removal of patients with hirsutism. It is indicated for use on all skin types (Fitzpatrick Skin Types 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. | Diode Laser Therapy Systems is intended to be used for hair removal of patients with hirsutism. It is indicated for use on all skin types (Fitzpatrick Skin Types 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 Elite iQ Laser System is indicated for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completion of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. | Same | | Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | | Class | II | II | II | Same | {7} | Device Characteristic | Subject Device | Predicate Device (K212978) | Reference Device 1 (K193426) | Discussion | | --- | --- | --- | --- | --- | | Configuration | Main Unit Handle Foot Control | Main Unit Handle Foot Control | Main Unit Handpiece Foot Control and Finger Control | Same | | Laser type | Diode Laser | Diode Laser | Alexandrite | Same | | Laser Wavelength | Class IV 808nm | Class IV 808nm | Unknown 755nm | Same | | Spot Size | 12mm × 24mm=2.88cm² | 1.2 cm × 2.4 cm=2.88 cm² | 2.5mm, 5mm, 7mm, 10mm, 12mm, 15mm, 18mm, 20mm, 22mm, & 24mm | Different 1 | | Fluence | 100J/cm² | 10-120 J/cm² | Up to 600J/ cm² | Different 2 | | Frequency | 1-10 Hz | 1-10 Hz | 0.5-10 Hz | Same | | Pulse Duration | 1~200ms | 10-300 ms | 0.5-300ms | Different 3 | | Power Supply | 110VAC (50/60Hz) | AC 100~230V/50/60Hz 2000VA | 208V~240V/50~60Hz 5500VA | Different 4 | | Dimension | 1260mm*560mm*700mm | 430×500×1030mm | Unknown | Different 5 | | Weight | 120kg | 65kg | Unknown | Different 6 | | Patient Contacting Material | Aluminum alloy, Sapphire | Aluminum alloy, Sapphire | 316 Stainless Steel | Same | {8} | Device Characteristic | Subject Device | Predicate Device (K212978) | Reference Device 1 (K193426) | Discussion | | --- | --- | --- | --- | --- | | Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Comply with ISO10993-1 | Same | | Sensitization | No evidence of Sensitization | No evidence of Sensitization | | | | Irritation | No evidence of Irritation | No evidence of Irritation | | | | Electrical Safety | Comply with IEC 60601-1 IEC 60601-2-22 | Comply with IEC 60601-1 IEC 60601-2-22 | Comply with IEC60601-1, IEC60601-1-22 | Same | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same | | Laser safety | IEC 60825-1 | IEC 60825-1 | IEC 60825-1 | Same | ## Comment Different 1: The subject device’s spot size of $12\mathrm{mm} \times 24\mathrm{mm}$ yields an irradiation area of $2.88~\mathrm{cm}^2$, which is exactly equal to the area $(2.88~\mathrm{cm}^2)$ of the primary predicate device (K212978). The difference in unit representation (mm vs. cm) is non-substantive. The spot size array of the reference device further confirms that various spot dimensions are commercially available and cleared for the same intended use. Different 2: The subject device utilizes a clinically equivalent single setting of $100\mathrm{J} / \mathrm{cm}^2$, which is solidly within the cleared range (10-120/125 J/cm²) of all referenced predicates. This fixed parameter simplifies operation while ensuring energy delivery remains within the well-established and proven therapeutic window for safe and effective hair removal. Different 3: The subject device operating range of $1 - 200\mathrm{ms}$ shares a substantial, clinically relevant overlap (10-200 ms) with the primary predicate device (K212978, 10-300 ms), ensuring equivalent laser-tissue interaction for hair removal. Furthermore, the lower end of our range is supported by the cleared parameters of the referenced device K193426, which has a validated range of 0.5-300 ms. This demonstrates that pulse durations at and below $10\mathrm{ms}$ are technically feasible and within the recognized safety profile of this device type. {9} Different 4: The differences in power supply specifications (e.g., 110VAC vs. 100-230VAC) reflect design adaptations for different regional electrical standards. These are external input specifications and do not affect the performance, calibration, or safety of the core therapeutic energy output system. The treatment delivery remains equivalent. Different 5: The differences in physical dimensions are related to the device's industrial design, internal component layout, and cooling system architecture. These variations do not affect the device's intended use, its laser output parameters, treatment efficacy, or safety profile. The subject device remains a console-based system intended for use in a clinical setting, similar to the predicates. Different 6: The increased weight correlates with the robust construction and use of materials that enhance device stability and longevity. This represents a performance improvement that does not adversely affect the devices deployment, operation, or safety profile. The core treatment mechanism remains unchanged ## 10. Substantially Equivalent (SE) Conclusion The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device (K212978). --- **Source:** [https://fda.innolitics.com/device/K260307](https://fda.innolitics.com/device/K260307) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com