LED Therapy Device (QLXY-01)

{0} **FDA U.S. FOOD & DRUG** ADMINISTRATION September 17, 2026 Beijing Nubway S&T 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: K261673 Trade/Device Name: LED Therapy Device (QLXY-01) 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 20, 2026 Received: May 21, 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. 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 U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261673 - Liya Meng Page 2 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. 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 {2} K261673 - Liya Meng Page 3 (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: 2026.09.17 20:23:22 -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) K261673 Device Name LED Therapy Device (QLXY-01) Indications for Use (Describe) The LED Therapy Device is intended for: -Blue light: (460-465nm)- to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. -Red light: (620-625nm)-for treatment of superficial, benign vascular and pigmented lesions. -Yellow light: ( 585-590nm)-treatment of periorbital wrinkles and rhytides. 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 The assigned 510(k) Number: K261673 ## 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: 2026/09/01 2. Sponsor Identification **Beijing Nubway S&T Co., Ltd.** 202, No.5 workshop, No.1 caida 3rd Road Nancai Shunyi District, Beijing China. 101300. Contact Person: Xiting Fan Position: Registered Manager Tel: +86-13716933250 Email: 1015932471@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: LED Therapy Device Model: QLXY-01 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 ### 5. Identification of Predicate Device(s) Predicate device: 510(k) Number: K202175 Product Name: OxyLight 2.0 Manufacturer: RAJA Trading Company Inc. ### 6. Device Description The LED Therapy Device, Model: QLXY-01, is an LED phototherapy device for Prescription Use in medical clinics and beauty salons. It uses specific wavelengths of light, produced by light emitting diodes (LEDs). The device produces light in the following regions of the light spectrum: -Blue light: (460-465nm) -Red light: (620-625nm) -Yellow light: (585-590nm) The core working principle of the LED Therapy Device is based on photochemical and photobiological effects. With its built-in LED light source, the device accurately emits red, blue and yellow light of specific wavelengths. This device's main components are the main unit (including power supply system, control system, display LCD screen), Lamp panel and lamp panel support frame. User interface software allows the operator to access and control all device functions. ### 7. Indication For Use Statement: The LED Therapy Device is intended for: -Blue light: (460-465nm)- to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. -Red light: (620-625nm)-for treatment of superficial, benign vascular and pigmented lesions. -Yellow light: (585-590nm)-treatment of periorbital wrinkles and rhytides. ### 8. Substantially Equivalent (SE) Comparison Table 1 General Comparison | Item | Proposed Device | Predicate Device K202175 | Remark | | --- | --- | --- | --- | | Device name | LED Therapy Device | Oxylight 2.0 | / | | Classification Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME | | Classification | II | II | SAME | 2/5 {6} 510(k) Summary | 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 | | Indications for use | The LED Therapy Device is intended for: -Blue light: (460-465nm)- to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. -Red light: (620-625nm)-for treatment of superficial, benign vascular and pigmented lesions. -Yellow light: ( 585-590nm)-treatment of periorbital wrinkles and rhytides. | The Oxylight 2.0 is intended for dermatological use by physicians and healthcare professionals for the following: LED Technology is intended for: -Blue LED - 465nm - to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. -Red LED 625nm- for treatment of superficial, benign vascular and pigmented lesions. -Yellow LED 590nm - treatment of periorbital wrinkles and rhytides. | SAME | | No. of LEDs | Each group of light boards contains 300 light beads, with 5 light boards forming one group, for a total of 1500 light beads | Panel – 840 Face Handpiece - 8 Body Handpiece - 18 | Analysis 1 | | Treatment Time | Not exceeding 20 minutes | 20 minutes | Analysis 2 | | Light Source | LED | LED | SAME | | Operation Interface | Display Screen | Display Screen | SAME | | Wavelength (Blue) | 460-465nm | 465nm ± 5nm | SAME | | Energy Output (Blue) | 54J/cm² | 54J/cm² | SAME | | Power Output (Blue) | 45mw/cm² | 45mw/cm² | SAME | | Wavelength (Red) | 620-625nm | 625nm ± 5nm | SAME | | Energy Output (Red) | 120 J/cm² | 120J/cm² | SAME | | Power Output (Red) | 100 mw/cm² | 100mw/cm² | SAME | 3 / 5 {7} 510(k) Summary | Wavelength (Yellow) | 585-590nm | 590nm ± 5nm | SAME | | --- | --- | --- | --- | | Energy Output (Yellow) | 42J/cm2 | 42J/cm2 | SAME | | Power Output (Yellow) | 35mw/cm2 | 35 mw/cm2 | SAME | | Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SAME | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME | | Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | Analysis 3 | #### Analysis: #### Analysis 1 The proposed device is different in No. of LEDs from the proposed device and predicate device (K202175). However, the therapeutic effect and harm of the final light energy are determined by the light energy acting on human body, which is energy output (J/cm \( ^{2} \) ). So, no matter the number of light sources will not affect the effect and risk of the final treatment. Additionally, by complying with IEC 60601-1, the mechanical and heat performance of the proposed device is determined to be accepted. Therefore, this difference will not affect safety and effectiveness of the proposed device #### Analysis 2 The maximum allowable treatment time of the subject device is same to the treatment time of the predicate device. While shorter treatment duration are permitted, the subject device cannot exceed 20 minutes under any operating condition. This maximum-time constraint is documented in the User manual Section 5.1, Section 6.1 and Section 6.3. No new safety-or-effectiveness risks are introduced by this difference. Therefore, this difference will not affect the safety and effectiveness of the proposed device. #### Analysis 3 The proposed device has been assessed for the requirement of biocompatibility testing as per ISO 10993-1. The proposed device is a non-contact phototherapy device for professional medical institutions. It does not contact with patients, so it does not need to be tested according to ISO 10993-1. ### 9. Non-Clinical Test Data Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1 Edition 3.2 2020-08, 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 4 / 5 {8} 510(k) Summary requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests ➤ IEC 60601-2-57 Edition 1.0 2011-01 Medical electrical equipment Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use ➤ IEC62471 First edition 2006-07 Photobiological safety of lamps and lamp systems ➤ IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation- Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems ➤ IEC 60601-1-6 Edition 3.2 2020-07, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability # 10. Clinical Test Conclusion No clinical study is included in this submission. # 11. Conclusion The conclusions drawn from the non-clinical testing demonstrate the proposed device is as safe and performs as well as the predicate device. Therefore, the proposed device is substantially equivalent to the predicate device. 5 / 5