Feather/numiere 05 06 07 (05)

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION December 24, 2025 Heat In A Click LLC. % Cassie Lee Primary Correspondent Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, Guangdong 510530 China Re: K253279 Trade/Device Name: Feather/numiere 05 06 07 (05) 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: September 26, 2025 Received: September 29, 2025 Dear Cassie Lee: 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 &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253279 - Cassie Lee 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} K253279 - Cassie Lee 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. Digitally signed by TANISHA L. HITHE -S DATE: 2025.12.24 00:17:34 -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} FORM FDA 3881 (8/23) 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: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K253279 | | | Device Name Feather/numiere 05 06 07 (05) | | | Indications for Use (Describe) Feather/numiere 05 06 07 (05) is an Over the-Counter (OTC) device intended for the use in treating wrinkles on the decolletage. | | | 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 K253279 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. 1. Date of the summary prepared: December 15, 2025 2. Submitter's Information Company Name: Heat In A Click LLC. Establishment Registration Number: 3008929787 Address: Numiere 1975 Tigertail blvd Dania FL 33004. Contact Person (including title): Guy Levi (CEO) Phone: 843-267-9860 Fax: / Post code: 33004 Email: Guy@palmnrg.com Application Correspondent: Contact Person: Cassie Lee Company Name: Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com Subject Device Information Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Common Name: Light based over the counter wrinkle reduction Trade Name: Feather/ numiere 05 06 07 Model Name: 05 Review Panel: General &amp; Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810 Regulatory Class: II 3. Predicate Device Information Predicate Device 1 Sponsor: My Blend Trade Name: myLEDmask Trademark: / Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Common Name: Light Based Over The Counter Wrinkle Reduction Model: / 510(k) Number: K223147 Review Panel: General &amp; Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810 Regulation Class: II Predicate Device 2 Sponsor: ISMART DEVELOPMENTS LTD Trade Name: décoLITE Model Name: / {5} Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Common Name: Light Based Over The Counter Wrinkle Reduction 510(k) Number: K242382 Review Panel: General &amp; Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810 Regulation Class: II ## 4. Device Description Feather/ numiere 05 06 07 (Models: 05) is an over-the-counter light-emitting diode (LED) device that emits energy for the treatment of wrinkles. The device works by simultaneously emitting 630nm±10nm, 830nm ±10nm wavelengths for the treatment of wrinkles on the neck and decolletage (upper chest). The device is designed in a flexible silicone panel that contains red (630nm±10nm) and near infrared (830nm±10nm) light-emitting diodes (LEDs). The device also contains a controller that controls the power on and off of the device, and regulates the intensity of the treatment by pressing buttons, and the controller displays the intensity level of the treatment as well as the duration of the treatment. ## 5. Intended Use / Indications for Use Feather/numiere 05 06 07 (05) is an Over the-Counter (OTC) device intended for the use in treating wrinkles on the decolletage. ## 6. Comparison to predicate device Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness. | Elements of Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | | --- | --- | --- | --- | --- | | Company | Heat In A Click LLC. | MyBlend | ISMART DEVELOPMENTS LTD | -- | | Trade Name | Feather/ numiere 05 06 07 | MyLedMAsk | d<coLITE | -- | | 510(k) Number | K253279 | K223147 | K242382 | -- | | Product Code | OHS | OHS | OHS | Same | | Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | | FDA Device Classification | Class II | Class II | Class II | Same | | Intended use/ Indication for Use | Feather/numiere 05 06 07 (05) is an Over the-Counter (OTC) device intended for the use in treating wrinkles on the decolletage. | MyLedMask is an over-the-counter device that is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles | The décoLITE LED device is an over-the-counter device that is intended for the use in the treatment of wrinkles in the decolletage area. | Similar Note 1 | {6} | Elements of Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | | --- | --- | --- | --- | --- | | Environment of Use | OTC | OTC | OTC | Same | | Intended Location of Use | Neck and decolletage (upper chest) | Face and neck | Decolletage (upper chest) | Similar Note 1 | | Power Source | Adapter Input: 100-110Vac, 50/60Hz; Adapter Output: 5Vdc, 1A Lithium battery: 3.7Vdc,1200mAh, 4.44Wh | Voltage: 100 to 240 volts, AC Frequency: 50-60Hz Intensity: 0.35 A Battery: NiMH 1.7 Ah | Rechargeable lithium polymer batter | Similar Note 2 | | Wavelengths | 630nm±10nm; 830nm±10nm | Red: 630 nm NIR: 850 nm | Red: 630nm ± 10nm NIR: 830nm ± 10nm | Same | | Irradiance source | LEDs | LEDs | Light emitting diodes (LEDs) | Same | | Total Intensity (mw/cm²) | Max. 30mW/cm² (Level 1: 12-16mw/cm²; Level 2: 20-25mw/cm²; Level 3: 26-30mW/cm²) | 18.7 mW/cm² (average of 6 measurement location (including one on the neck) between 10 to 27 mW/cm²) | 30mW/cm² total | Same | | Treatment time | 10 min; 5× weekly, 6 weeks | According to skin phototype, daily - 1 fair skin: 5 min 35 (335 s) - 2 moderately dark skin: 11 min 10 (670 s) - 3 dark skin: 13 min 55 (835 s) during 6 to 8 weeks | 600 seconds (10 minutes); 5× weekly, 6 weeks | Same | | Safety and EMC | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-57 IEC 60601-2-83 IEC 62471 IEC 62133-2 | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-57 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-57 IEC 60601-2-83 IEC 62471 IEC 62133-2 | Same | 3 / 5 {7} Note 1: Although the "Intended use/Indication for Use" of the subject device is slightly different from the predicate device K223147 in description and the K242382, all of them are designed to use same/similar treatment wavelengths for wrinkles treatment on the face with the same or similar irradiance source (LEDs) and intensity. So, the difference between the subject device and the predicate devices will not raise any safety or effectiveness issues. Note 2: Although the subject device's description in "Power supply" is slightly different from that of the predicate devices, all of them are powered by Lithium-Ion batteries, which comply with IEC 62133-2's requirements. Besides, both the subject device and the predicate devices conducted safety tests according to the IEC 60601 series standards, and the test results are in compliance with the safety standards' requirements. So, the difference between the subject device and the predicate device will not raise any safety or effectiveness issues. 7. Test Summary 7.1 Non-Clinical Tests Performed 1) Electrical safety, and electromagnetic compatibility Test Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility: - IEC 60601-1 2020-08 Edition 3.2 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - IEC 60601-1-11 Edition 2.1 2020-07 Medical Electrical Equipment - Part 1: 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 60601-2-57 Edition 2.0 2023-07 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. - IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. - IEC 60601-2-83 Edition 1.1 2022-12 Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment. - IEC 62133-2 Edition 5.0 2021-09 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications – Part 2: Lithium systems. - IEC 62471 Edition 1.0 2006-07 Photobiological safety of lamps and lamp systems 2) Software verification and validation Software verification and validation testing were conducted and basic level of documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions (2023)." The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury. 3) Usability validation Usability testing was conducted on the Feather/ numiere 05 06 07 (Models: 05), which complies with IEC 62366-1 and IEC 60601-1-6. 7.2 Summary of Clinical Performance {8} Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively. 8. Final Conclusion: The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated device K223147 and K242382. 5 / 5