LED Beauty Mask (RLBXX)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION November 13, 2025 ATOP Lighting Co., Ltd. Tse Adrian Registration Representative 4th. Floor, Building C, No. 3, Jian'an Road Tangwei Community, Fuhai Street, Baoan District Shenzhen City, Guangdong province 518110 China Re: K252308 Trade/Device Name: LED Beauty Mask (RLBXX) 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 Dated: July 24, 2025 Received: July 24, 2025 Dear Tse Adrian: 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} K252308 - Tse Adrian 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 systems (QS) regulation (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} K252308 - Tse Adrian 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 Hithe Digitally signed by Tanisha Hithe Date: 2025.11.13 20:20:39 -05'00" 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} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K252308 | ? | | Please provide the device trade name(s). | | ? | | LED Beauty Mask (RLBXX) | | | | Please provide your Indications for Use below. | | ? | | The LED Beauty Mask is an over-the-counter device that is intended for use in the treatment of full-face wrinkles. | | | | Please select the types of uses (select one or both, as applicable). | ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} atop Lighting ATOP Lighting Co., Ltd. # 510(k) Summary # K252308 ## Submitter Information - Company: ATOP Lighting Co., Ltd. - Address: 4th. Floor, Building C, No. 3, Jian'an Road, Tangwei Community, Fuhai Street, Baoan District, Shenzhen City - Phone: +086-15915873605 - Contact: Tse Adrian, Registration representative - Mail box: certificate@atophort.com ## Device Information - Trade/Device Name: LED Beauty Mask - Model: RLBXX - Common Name: Light-Based Over-The-Counter Wrinkle Reduction - Classification regulation: - Regulation number: 21 CFR 878.4810 - Regulation Description: Laser surgical instrument for use in general and plastic surgery and in dermatology - Review Panel: General & Plastic Surgery - Product Code: OHS - Device Class: Class II - Submission number: # K252308 ## Subject Device Description This product is based on low-energy red light therapy (LED Phototherapy), which achieves through precise wavelength control: Wavelength selection: Using 630 red light and 830nm near-infrared light to treat wrinkle for 25-50 years women The main body of the mask is made of medical-grade silicone, with a total weight of $\leqslant 300\mathrm{g}$, and an elastic headband, which can be worn for a long time without pressure. ## Predicate Device Information - Predicate Device: LG PRA.L DERMA LED MASK - Manufacturer: LG Electronics, Inc. - 510(k) number: K183671 Page 1 {5} atop Lighting ATOP Lighting Co., Ltd. Indication of use: The LG PRA.L DERMA LED MASK is an over the counter device that is intended for the use in the treatment of full face wrinkles. Page 2 {6} atop Lighting ATOP Lighting Co., Ltd. # Indications for Use - Subject device The LED Beauty Mask is an over-the-counter device that is intended for use in the treatment of full-face wrinkles. Comparison of Technological Characteristics with the Predicate Device | Comparison Items | Subject Device:LED Beauty Mask | Predicate Device 1:LG PRA.L DERMA LEDMASK(K183671) | | --- | --- | --- | | Classification & Intended Use | | | | Classification | OHSClass II21 CFR 878.4810 | OHSClass II21 CFR 878.4810 | | Intended use | The LED Beauty Mask is an over-the-counter device that is intended for use in the treatment of full-face wrinkles. | The LG PRA.L DERMA LEDMASK is an over the counter device that is intended for the use in the treatment of full face wrinkles. | | Location for use | Face | Face | | Patient Population | For use in adults | For use in adults | | OTC or prescription | Over-the-Counter | OTC | | Classification name | Light based over the counter wrinkle reduction | Light based over the counter wrinkle reduction | | Comparison Statement | The subject device enjoys the same classification and intended use with the predicate device. | | | Technological Characteristics | | | | --- | --- | --- | | Principle / Method of Operation | The subject device adopts light emitting diodes | The LG PRA.L DERMA LED MASK is a device which | {7} atop Lighting ATOP Lighting Co., Ltd. | | (LED) in the red (630nm±5nm) + infrared (830nm±5nm) spectrum to irradiate on the face to realize its therapeutic effect. | allows emission of LED light in the RED (637 nm) and IR (854 nm) spectrum on to the face. | | --- | --- | --- | | Wavelength | 630nm, 830nm | 637nm, 854nm | | Material | Mask frame: Silicone Eye shade: Silicone Controller frame: PP Adaptor frame: PP | Mask frame: PC Eye frame: PP Eye shield: Silicone Viewing shield: ABS plastic Controller frame: PP Adaptor frame: PP Cradle frame: PP | | Dimensions (mm) | Mask Frame: 391 x 207 x 6 Controller: 95 x 55 x 19 Adaptor: 56 x 35 x 21.5 | LED Mask: 178.8 x 225 x 89 Controller: 40 x 30 x 110 Adaptor: 87x 44 x 28 Cradle: 180 x 229 x 167.8 | | Net weight | LED Mask: 164 g Controller: 66 g Adaptor: 60 g | LED Mask: 225 g Controller: 84 g Adaptor: 75 g Cradle: 380 g | | Power supply | Input: 100 -240 V Frequency: 50 / 60 Hz Output: 5V 1A | Input: 100 -240 V Frequency: 50 / 60 Hz Output: 5V 1A | | Light source | Light Emitting Diodes | Light Emitting Diodes | Page 4 {8} atop Lighting ATOP Lighting Co., Ltd. | | (LED) | (LED) | | --- | --- | --- | | Number of LEDs | Total 128 LEDs (64 of them are for 630 nm and the rest 64 of them are for 830 nm) | Total 160 LEDs (80 of them are for 637 nm and the rest 80 of them are for 854 nm) | | LED power | 25 mW/cm2 total | 25 mW/cm2 total | | Electronic power | Input: AC 100V ~ 240V Frequency: 50Hz/60Hz Output: 5V 1A | Input: AC 100V ~ 240V Frequency: 50Hz/60Hz Output: 5V 2A | | Shape design | Mask type | Mask type | | Battery | Lithium-ion | Lithium-ion | | Treatment time | 9 minutes daily 5 days per week for 8 weeks | 9 minutes daily 5 days per week for 8 weeks | | Comparison statement | The subject device has almost the same technological characteristics with the predicate device, and their slight difference in wavelength, material and Dimensions will not affect the core usage of the devices or validated by relevant standard evaluation or not bringing new safety and effectiveness concerns, thus will not affecting the substantial equivalence comparison. their differences are not affecting the core usage of the devices The efficiency of the subject device was able to reach an equivalence level of the predicate device. | | | Patient-Contacting Materials | Silicone rubber | Not know | Difference | | --- | --- | --- | --- | | Electrical Safety | Verified according | IEC 60601-1 | Identical | {9} atop Lighting ATOP Lighting Co., Ltd. | | to IEC 60601-1 | | | | --- | --- | --- | --- | | EMC | Verified according to IEC 60601-1-2 | IEC 60601-1-2 | Identical | | Biocompatibility | Verified according to ISO 10993-5 and ISO 10993-10 | Not know | Difference | | Comparison Statement | The substantial equivalence of the subject device has been evaluated according to the FDA-recognized standards. | | | # 5.6.1 Comparison summary First, the subject device enjoys identical classification and intended use with the predicate device, which forms the foundation of their substantial equivalence. Secondly, most technological characteristics have substantial equivalence differences is below: | Difference item | | --- | | Principle / Method of Operation | | Wavelength | | Material | | Dimensions | | Net weight | | Number of LEDs | | Patient-Contacting Materials | | Biocompatibility | # Discussion of Tests Performed 1. Clinical Test {10} atop Lighting ATOP Lighting Co., Ltd. Clinical testing was not performed for the subject device as part of the submission. # 2. Non-Clinical Tests The subject device was tested/analyzed according to the following standards in order to ensure substantial equivalence: | | Standard Designation Number | Title of Standard | | --- | --- | --- | | Electrical Safety | IEC 60601-1: 2020 | Medical electrical equipment Part 1: General requirements for basic safety and essential performance | | Electromagnetic Compatibility | IEC 60601-1-2: 2020 | Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests | | Home environment use requirement | 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 | {11} atop Lighting ATOP Lighting Co., Ltd. | | | electrical systems used in the home healthcare environment | | --- | --- | --- | | Biocompatibility | 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: Test for skin sensitization | | | ISO 10993-23: 2021 | Biological evaluation of medical devices—Part 23: Tests for irritation | # Conclusion From the above analysis, it is proper to conclude that the subject device will be as safe and effective for usage as the listed predicate devices, K183671 that have already been on the U.S. market. Date the Summary was prepared: Oct. 08, 2025