← Product Code [OHS](/productcode/OHS) · K261601 # LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) (K261601) _Shenzhen Chuangtong Yigou Technology Co., Ltd. · OHS · Aug 7, 2026 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K261601 ## Device Facts - **Applicant:** Shenzhen Chuangtong Yigou Technology Co., Ltd. - **Product Code:** [OHS](/productcode/OHS.md) - **Decision Date:** Aug 7, 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 LED Light Therapy Mask is an over-the-counter (OTC) device intended for the following uses: For Red+NIR Mode: Treatment of full-face wrinkles. For Blue+Red+NIR mode: Treatment of mild to moderate inflammatory acne. ## Device Story Wearable LED phototherapy mask for home use; treats facial wrinkles and acne. Device comprises mask body with LEDs, controller, straps, and rechargeable lithium battery. Operates in three modes: Cleanse (Blue 460nm+Red 620nm+NIR 850nm), Revitalize (Red 620nm+NIR 850nm), and Stabilize (Blue 460nm+Red 620nm+NIR 850nm). User operates controller to select mode and power device. LEDs provide narrow-band light therapy to facial skin. Output is light energy; intended to improve skin appearance and reduce acne inflammation. No clinical decision-making or external data processing involved. ## Clinical Evidence Bench testing only. Evidence includes biocompatibility testing per ISO 10993-1, electrical safety and EMC testing per IEC 60601-1, 60601-1-2, 60601-1-11, and 60601-2-83, photobiological eye safety per IEC 62471, and software verification/validation. ## Technological Characteristics Wearable mask; light source: LEDs (Blue 460nm, Red 620nm, NIR 850nm). Power: 3.7V 1200mAh Li-ion battery. Biocompatibility: ISO 10993-5, -10, -23. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62471. Irradiance: 8-22 mW/cm² depending on mode. Non-sterile. ## 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 - LED Light Therapy Machine (Model: G1, G3, G4, G6) ([K242638](/device/K242638.md)) ## Reference Devices - LED light therapy mask (Model: SKB-2318L) ([K243040](/device/K243040.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 August 7, 2026 Shenzhen Chuangtong Yigou Technology Co., Ltd. % Candice Qiu Registration specialist Feiying Drug & Medical Consulting Technical Service Group Rm.2401 Zhenye International Business Center, # 3101-90, Qianhai Rd. Shenzhen, Guangdong 518052 China Re: K261601 Trade/Device Name: LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) 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: OHS, OLP Dated: May 14, 2026 Received: May 14, 2026 Dear Candice Qiu: 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} K261601 - Candice Qiu 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). {2} K261601 - Candice Qiu Page 3 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: 2026.08.07 13:51:12 -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) K261601 Device Name LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) Indications for Use (Describe) The LED Light Therapy Mask is an over-the-counter (OTC) device intended for the following uses: For Red+NIR Mode: Treatment of full-face wrinkles. For Blue+Red+NIR mode: Treatment of mild to moderate inflammatory acne. 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} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k) Summary K261601 # 10(k) Summary #K261601 "510(k) Summary" as required by 21 CFR Part 807.92. Date prepared: 2026-8-7 # I. Submitter Shenzhen Chuangtong Yigou Technology Co., Ltd Room 2218, Rongchuang Zhihui Building A, Shangfen Community, Minzhi Street, Longhua District, Shenzhen, China Kingway Hong Manager Tel: +86 13410362992 Email: kingway.hong@ctonetech.com # II. Device Name of Device: LED Light Therapy Mask Model(s): M01, M02, M03, M05, M06, M07, M08. Regulation Name: Light Based Over The Counter Wrinkle Reduction; Over-The-Counter Powered Light Based For Acne Regulatory Class: II Product Code: OHS, OLP Regulation Number: 21 CFR 878.4810 # III. Predicate Device and reference device Page 1 of 8 {5} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k) Summary K261601 Predicate device: | Manufacturer | Predicate Device | 510(k) Number | Approval Date | | --- | --- | --- | --- | | Shenzhen Walton Technology Co., Ltd. | LED Light Therapy Machine (Model: G1, G3, G4, G6) | K242638 | November 27, 2024 | Reference device: | Manufacturer | reference device | 510(k) Number | Approval Date | | --- | --- | --- | --- | | Shenzhen Siken 3D Technology Development Co., Ltd. | LED light therapy mask (Model: SKB-2318L) | K243040 | December 20, 2024 | ## IV. Device Description The subject device LED Therapy Mask is a home use wearable LED phototherapy device whose purpose is to produce an even and narrow-band of light for the treatment of aesthetic indications including facial wrinkles and acnes. The subject device consists of a mask body unit that contains light emitting diodes (LEDs), a controller, straps and Charging cable. And the device is powered by built-in rechargeable lithium battery on the controller. The LEDs generate 3 kinds of light mode which include Cleanse mode (Blue 460nm+Red 620nm+Infrared 850nm), Revitalize mode (Red 620nm+Infrared 850nm) and Stabilize mode(Blue 460nm+Red 620nm+Infrared 850nm). A controller is connect to the mask body unit to control the device, such as turn on/off the device, switch LED output. And the straps used for securing the mask unit to the face part. ## V. Indications for Use The LED Light Therapy Mask is an over-the-counter (OTC) device intended for the following uses: Page 2 of 8 {6} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k) Summary K261601--- For Red+NIR Mode: Treatment of full-face wrinkles. For Blue+Red+NIR mode: Treatment of mild to moderate inflammatory acne. ## VI. Comparison of Technological Characteristics With the Predicate Device The LED Light Therapy Mask has the same intended use, mode of action and similar operational characteristics as the predicate device. Any minor differences between the subject device and the listed predicate device and reference device do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device and reference device for its intended use. Therefore, the LED Light Therapy Mask may be found substantially equivalent to its predicate device and reference device. LED Light Therapy Mask is compared with the following Predicate Device and reference device in terms of intended use, design, material, specifications, and performance: | Comparison Elements | Subject Device | Predicate Device | Reference Device | Remark | | --- | --- | --- | --- | --- | | 510(k) Number | K261601 | K242638 | K243040 | / | | Trade name | LED Light Therapy Mask | LED Light Therapy Machine | LED light therapy mask | / | | Model | M01, M02, M03, M05, M06, M07, M08 | G1, G3, G4, G6 | SKB-2318L | / | | Manufacturer | Shenzhen Chuangtong Yigou Technology Co., Ltd. | Shenzhen Walton Technology Co., Ltd. | Shenzhen Siken 3D Technology Development Co., Ltd. | / | | Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 21 CFR 890.5500 | 21 CFR 878.4810 | Same | | Classification Name | Light Based Over The Counter Wrinkle Reduction (OHS); Over-The-Counter Powered Light Based Laser For Acne(OLP). | Light Based Over The Counter Wrinkle Reduction (OHS); Over-The-Counter Powered Light Based Laser For | Light Based Over The Counter Wrinkle Reduction (OHS); Over-The-Counter Powered Light Based Laser For | Same | Page 3 of 8 {7} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k) Summary K261601 | Comparison Elements | Subject Device | Predicate Device | Reference Device | Remark | | --- | --- | --- | --- | --- | | 510(k) Number | K261601 | K242638 | K243040 | / | | | | Acne(OLP); Infrared, Therapeutic Heating(ILY) | Acne(OLP) | | | Product code | OHS, OLP | OHS, OLP, ILY | OHS, OLP | Same | | Device classification | Class II | Class II | Class II | Same | | Indication for use/ Intended use | The LED Light Therapy Mask is an over-the-counter (OTC) device intended for the following uses: For Red+NIR Mode: Treatment of full-face wrinkles. For Blue+Red+NIR mode: Treatment of mild to moderate inflammatory acne. | Red light: Treatment of full-face wrinkles. Blue light: Treatment of mild to moderate inflammatory acne. Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Mixed light: Treatment of mild to moderate inflammatory acne. | LED Light Therapy Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne. | Same | | Prescription or OTC | OTC | OTC | OTC | Same | | Dimension | Approx. 337.5mm*231.22mm*8.52mm | Not publicly available | Model SKB-2318L : 411*195*4mm | Different | Page 4 of 8 {8} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k) Summary K261601 | Comparison Elements | Subject Device | Predicate Device | Reference Device | Remark | | --- | --- | --- | --- | --- | | 510(k) Number | K261601 | K242638 | K243040 | / | | Power supply | DC 3.7V 1200 mAh Li-ion Battery | Input: 100-240 V~, 50/60Hz, 0.8A Output: DC 12V, 2A | Input: AC 100-240V 50-60Hz 0.3A Output: DC 5V 1A 3.7V 650mAh Li-ion Battery 3.7V1000mAh Li-ion Battery | Different | | Sterilization | Not applicable | Not applicable | Not applicable | Same | | Light source | Light Emitting Diodes | Light Emitting Diodes | Light Emitting Diodes | Same | | Location for use | Face | Face and body | Face | Same | | Wavelength | Blue: 460 nm±10nm Red: 620nm±10nm Near-Infrared: 850nm±10nm | Red: 620nm Blue: 460nm Infrared: 850nm Mixed: 620nm and 850nm and 460nm | SKB-2318L: Blue: 460nm±10nm Red: 620nm±10nm Infrared: 850nm±10nm | Same | | Irradiance (mW/cm²) | There are three modes: Cleanse mode: Blue+Red+Infrared: 9-12 mW/cm² Revitalize mode: Red+Infrared: 8-22 mW/cm² Stabilize mode: Blue+Red+Infrared: 9-12 | Red light: 2.0~3.0 Blue light: 2.0~4.0 Infrared light: 2.0~4.0 Mixed light: 9.0~12.0 | SKB-2318L: Mode 1: Red: 3.5~10mW/cm² Mode 2: Blue: 2.5~8mW/cm² Mode 3: Red+Infrared Light: 6~27mW/cm² | Similar | Page 5 of 8 {9} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k) Summary K261601--- | Comparison Elements | Subject Device | Predicate Device | Reference Device | Remark | | --- | --- | --- | --- | --- | | 510(k) Number | K261601 | K242638 | K243040 | / | | | mW/cm^{2} Error: ±20% | | | | | Treatment time | 20 minutes | Manual Mode (Mode: M1, M2, M3, M4): 15 minutes each time; Automatic Mode (Mode C): 10 minutes each time. 3-4 treatment a week, reduce to 1-2 | It is recommended to use it for 10 minutes a day, 3 times per week. | Different | | Compliance with voluntary standards | IEC 60601-1; IEC 60601-1-2; IEC 60601-1-11; IEC 60601-2-83; IEC 62471 | IEC 60601-1; IEC 60601-1-2; IEC 60601-1-11; IEC 60601-2-57; IEC 62471 | IEC 60601-1; IEC 60601-1-2; IEC 60601-1-11; IEC 60601-2-57; IEC 62471 IEC 62133-2 | Same | | Biocompatibility | ISO 10993-5 ISO 10993-10 ISO 10993-23 | ISO 10993-5 ISO 10993-10 ISO 10993-23 | All body-contacting materials are complied with ISO10993-5, ISO 10993-10 and ISO 10993-23 | Same | Page 6 of 8 {10} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k) Summary K261601 ## VII. Performance Data The following performance data were provided in support of the substantial equivalence determination. ### 1) Biocompatibility Evaluation - The biocompatibility evaluation for the body-contacting components of the LED Light Therapy Mask was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020', as recommended by FDA. ### 2) Electrical Safety and EMC Electrical safety and EMC testing was performed to, and passed, as per the following standards: - IEC 60601-1-2: 2020, Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance – Collateral standard: electromagnetic compatibility. - IEC 60601-1: 2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance . - IEC 60601-1-11: 2020, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. - IEC 60601-2-83: 2022, Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment. ### 3) Eye Safety - IEC 62471:2006, Photobiological safety of lamps and lamp systems ### 4) Software Verification and Validation Software documentation consistent with *Basic Documentation level* was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. Page 7 of 8 {11} Shenzhen Chuangtong Yigou Technology Co., Ltd 510(k) Summary K261601 ### VIII. Conclusions Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device LED Light Therapy Mask is as safe, as effective, and performs as well as the legally marketed predicate devices. Page 8 of 8 --- **Source:** [https://fda-staging.innolitics.com/device/K261601](https://fda-staging.innolitics.com/device/K261601) **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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