LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 16, 2026 Guangdong Newdermo Biotech Co., Ltd. JunYi Xing Certificate Engineer Bldg. 70(C28), # 9 Huateng Rd., Jinshan Village, Shiqi Town, Panyu District Guangzhou, Guangdong 511450 China Re: K261370 Trade/Device Name: LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NFO, OHS, OLP Dated: August 11, 2026 Received: August 12, 2026 Dear JunYi Xing: 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. 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" {1} K261370 - JunYi Xing Page 2 (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). 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). {2} K261370 - JunYi Xing Page 3 Sincerely, # Tushar Bansal -S for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {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. | K261370 | ? | | Please provide the device trade name(s). | | ? | | LED Light Therapy Mask (LED Face Mask Pulse FAC06NA) | | | | Please provide your Indications for Use below. | | ? | | 1.Red light + Near-Infrared light: Intended for treat full face wrinkles;2.Red light + Amber light + Dark Red light + Deep Near-Infrared light: Intended for treat full face wrinkles;3.Dark Red light + Deep Near-Infrared light: Intended for treat full face wrinkles;4.Blue light: Intended for treatment of mild to moderate inflammatory acne;5.The Pulse mode is indicated for facial stimulation. | | | | Please select the types of uses (select one or both, as applicable). | □ Prescription Use (21 CFR 801 Subpart D)□ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | □ Neonates/Newborns (Birth to < 29 days old)□ Infants (29 days old to < 2 years old)□ Children (2 years old to < 12 years old)□ Adolescents (12 years old to < 22 years old)□ Adults (22 years old and greater) | ? | {4} Traditional 510(k) Submission of LED Light Therapy Mask # 510 (K) Summary K261370 Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92 # 1. Submitter: | 510(k) owner's name: | Guangdong Newdermo Biotech Co., Ltd. | | --- | --- | | Establishment Registration Number: | 3013178978 | | Address: | Building 70(C28), No.9 Huateng Road, Jinshan Village, Shiqi Town, Panyu District, Guangzhou, Guangdong, 511450, P.R. CHINA | | Tel: | +86 15012419132 | | Contact person (including title): | Jiayi Feng(RA) | | Email: | sales13@newdermo.com | | Preparing date: | September 09, 2026 | # 2. Device name and classification: | Device Name: | LED Light Therapy Mask | | --- | --- | | Model: | LED Face Mask Pulse FAC06NA | | Classification Name | Stimulator, Transcutaneous Electrical, Aesthetic Purposes Light Based Over The Counter Wrinkle Reduction Lamp, Infrared, Therapeutic heating | | Product code: | NFO, OHS, OLP | | Regulation Number | 21 CFR 882.5890 | | Regulatory Class: | Class II | | Review Panel: | Neurology | # 3. Premarket Notification Class III Certification and Summary Not applicable, the subject device is Class II. # 4. Predicate Device(s): # 1) Predicate device1 | Sponsor: | Xtreem Pulse LLC | | --- | --- | | Device name: | PureLift GLOW | | 510(k) Number: | K243587 | Guangdong Newdermo Biotech Co.,Ltd 1 / 14 {5} Traditional 510(k) Submission of LED Light Therapy Mask | Regulation Number | 21 CFR 882.5890 | | --- | --- | | Classification Name | Stimulator, Transcutaneous Electrical, Aesthetic Purposes Light Based Over The Counter Wrinkle Reduction | | Product Code: | NFO, OHS | | Regulatory Class: | Class II | | Review Panel: | Neurology | # **2) Predicate device2** | Sponsor: | Light Tree Ventures Europe B.V. | | --- | --- | | Device name: | Q-Rejuvalight Pro Facewear (Model: P19-0023) | | 510(k) Number: | K230042 | | Regulation Number | 21 CFR 878.4810 | | Classification Name | Light Based Over The Counter Wrinkle Reduction Over-The-Counter Powered Light Based Laser For Acne | | Product Code: | OHS, OLP | | Regulatory Class: | Class II | | Review Panel: | General & Plastic Surgery | # **3) Predicate device3** | Sponsor: | HarparGrace International | | --- | --- | | Device name: | Shani Darden LED light therapy mask | | 510(k) Number: | K214103 | | Regulation Number | 21 CFR 878.4810 | | Classification Name | Light Based Over The Counter Wrinkle Reduction Over-The-Counter Powered Light Based Laser For Acne | | Product Code: | OHS, OLP | | Regulatory Class: | Class II | | Review Panel: | General & Plastic Surgery | # **4) Predicate device4** | Sponsor: | Shenzhen Qianyu Technology Co., Ltd. | | --- | --- | | Device name: | Wrinkle Treatment Device (JM2) | | 510(k) Number: | K240360 | | Regulation Number | 21 CFR 878.4810 | Guangdong Newdermo Biotech Co.,Ltd 2 / 14 {6} Traditional 510(k) Submission of LED Light Therapy Mask | Classification Name | Light Based Over The Counter Wrinkle Reduction | | --- | --- | | Product Code: | OHS | | Regulatory Class: | Class II | | Review Panel: | General & Plastic Surgery | # **5) Predicate device5** | Sponsor: | Shenzhen Qianyu Technology Co., Ltd. | | --- | --- | | Device name: | Wrinkle Treatment Device (JM2) | | 510(k) Number: | K230293 | | Regulation Number | 21 CFR 878.4810 | | Classification Name | Light Based Over The Counter Wrinkle Reduction Over-The-Counter Powered Light Based Laser For Acne | | Product Code: | OHS, OLP | | Regulatory Class: | Class II | | Review Panel: | General & Plastic Surgery | # **6) Predicate device 6** | Sponsor: | Ya-Man, Ltd. | | --- | --- | | Device name: | Medi Lift PLUS | | 510(k) Number: | K220198 | | Regulation Number | 21 CFR 882.5890 | | Classification Name | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | | Product Code: | NFO | | Regulatory Class: | Class II | | Review Panel: | Neurology | # **7) Predicate device7** | Sponsor: | Shenzhen Siken 3D Technology Development Co., Ltd. | | --- | --- | | Device name: | Multi-functional Facial Beauty Device ( SKB-1703, SKB-1803, SKB-1909, SKB-2003, SKB-2109, SKB-2129, SKB-2208PRO, SKB-2209) | | 510(k) Number: | K252146 | | Regulation Number | 21 CFR 882.5890 | | Classification Name | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | Guangdong Newdermo Biotech Co.,Ltd 3 / 14 {7} Traditional 510(k) Submission of LED Light Therapy Mask Product Code: NFO Regulatory Class: Class II Review Panel: Neurology ### **5. Reason for Submission** New device, there were no prior submissions for the device. ### **6. Pre-Submission, IDE** Not applicable, there is no prior submission. ### **7. Device Description:** This LED Light Therapy Mask is designed to provide comprehensive facial care solutions through multiple professional modes. The F1 (Red light + Near-Infrared light, 630 nm+830 nm), F2(Red light + Amber light + Dark Red light + Deep Near-Infrared light, 630 nm +605 nm+ 660nm + 880nm), and F3(Dark Red light + Deep Near-Infrared light, 660 nm +850 nm) modes are intended for the treatment and improvement of full-face wrinkles. The F4 mode (Blue, 415nm)is specifically designed for the auxiliary treatment of mild to moderate inflammatory acne. Additionally, the Pulse mode have 8 levels, which is indicated for facial electrical stimulation. User cannot use the LED functions and pulse functions simultaneously LED Light Therapy Mask consists of a face mask, a controller, straps (two long and two short, silicone), and a charging cable. ### **8. Intended Use:** 1.Red light + Near-Infrared light: Intended for treat full face wrinkles; 2.Red light + Amber light + Dark Red light + Deep Near-Infrared light: Intended for treat full face wrinkles; 3.Dark Red light + Deep Near-Infrared light: Intended for treat full face wrinkles; 4.Blue light: Intended for treatment of mild to moderate inflammatory acne; 5.The Pulse mode is indicated for facial stimulation. Guangdong Newdermo Biotech Co.,Ltd 4 / 14 {8} Traditional 510(k) Submission of LED Light Therapy Mask # 9. Predicate Device Comparison Comparison Table for Product Code NFO | Item | Subject Device | Predicate Device1 | Predicate device 6 | Predicate device7 | Comparison Result | | --- | --- | --- | --- | --- | --- | | Trade name | LED Light Therapy Mask | PureLift GLOW | Medi Lift PLUS | Multi-functional Facial Beauty Device ( SKB-1703, SKB-1803, SKB-1909, SKB-2003, SKB-2109, SKB-2129, SKB-2208PRO, SKB-2209) | / | | 510 (k) number | K261370 | K243587 | K220198 | K252146 | / | | Manufacturer | Guangdong Newdermo Biotech Co., Ltd. | Xtreem Pulse, LLC | Ya-Man, Ltd. | Shenzhen Siken 3D Technology Development Co., Ltd. | / | | Regulation number | 21 CFR 882.5890 21 CFR 878.4810 | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | Same | | Regulation Name | Stimulator, Transcutaneous Electrical, Aesthetic Purposes; Light Based Over The Counter Wrinkle Reduction; Over-The-Counter Powered Light Based Laser For Acne | Stimulator, Transcutaneous Electrical, Aesthetic Purposes; Over-The-Counter Powered Light Based Laser For Acne | Stimulator, Transcutaneous Electrical, Aesthetic Purposes; | Stimulator, Transcutaneous Electrical, Aesthetic Purposes; | Similar Note1 | | Product code | NFO, OHS, OLP | NFO, OLP | NFO | NFO | Similar Note1 | | Classification | II | II | II | II | Same | | Indications for use/ Intended use | 1.Red light + Near-Infrared light: Intended for treat full face wrinkles; 2.Red light + Amber light + Dark Red light + Deep Near-Infrared light: Intended for treat full face wrinkles; 3.Dark Red light + Deep Near-Infrared light: Intended for treat full face | Intended for facial and neck stimulation, treatment of wrinkles, treatment of mild to moderate inflammatory acne,and indicated for over-the-counter cosmetic use. | The Medi Lift PLUS is intended for facial stimulation and indicated for over-the-counter cosmetic use. | Multi-functional Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial stimulation through MC(micro-current) mode. | Similar Note2 | Guangdong Newdermo Biotech Co.,Ltd 5 / 14 {9} Traditional 510(k) Submission of LED Light Therapy Mask | | wrinkles; 4.Blue light: Intended for treatment of mild to moderate inflammatory acne; 5.The Pulse mode is indicated for facial stimulation. | | | | | | --- | --- | --- | --- | --- | --- | | Location for use | Face | Face | Cheeks | Face | Similar Note2 | | OTC or prescription | OTC | OTC | OTC | OTC | Same | | Power supply | Input:DC 5.0V , 1A; Li-ion Polymer Battery: DC 3.7V, 2000mAh, 7.4Wh | One 3.7V Battery | One 3.7 V Lithium ionbattery/one signalgenerator | N/A | Similar Note3 | | Power Source | Lithium-Ion Battery (rechargeable) | Battery | Lithium-Ion Battery | Lithium-Ion Battery (rechargeable) | Similar Note4 | | Waveform | Pulsed Biphasic | Pulses monophasic, alternating polarity | Symmetric Pulsed Biphasic and Quadphasic | Pulse-symmetric, biphasic, rectangular wave | Similar Note5 | | Shape | Rectangular pulses | Rectangular pulses | Rectangular pulses | Rectangular pulses | Similar Note5 | | Maximum Output Current | 11mA@500 Ω ± 10% | 9mA(@500 Ω) 4.4mA(@2k Ω) 1.2mA (@10k Ω) | 3.22 mA@500 Ω (±20%) | 32mA@500 Ω 14mA @2k Ω 3.7mA @10k Ω | Similar Note5 | | Maximum Output Voltage | 5.5Vpp@500 Ω ± 10% | 20Vpp@500 Ω ± 10% 32V@2k Ω ± 10% 44V@4k Ω ± 10% | 39.9Vpp@500 Ω (±20%) | 16Vpp@500 Ω 28V@2k Ω 37V@4k Ω | Similar Note5 | | Output Tolerance | ± 1mA | ± 1mA | N/A | ± 10% | Similar Note5 | | Pulse Width | 300 μs | 4 μs | 152/168/192 μs +10% (@2.5-100Hz), 52 μs +10% (@1kHz) | 4 μs | Similar Note5 | | Frequency (Hz) | 49.5Hz | 1.37kHz~ 1.73kHz | 2.5Hz, 5 Hz, 6Hz, 7Hz, 8Hz, 9Hz, 10 Hz, 20Hz, 25 Hz, 33 Hz, 50Hz, 66 Hz, 100Hz, 1kHz | 1.6kHz | Similar Note5 | | Symmetrical Phases | Non multiphasic | Non multiphasic | Yes | Yes | Similar Note5 | Guangdong Newdermo Biotech Co.,Ltd 6/14 {10} Traditional 510(k) Submission of LED Light Therapy Mask | Phase Duration | 300 μs | 4 μs | 38/42/48 μs +10% (@2.5-100Hz), 26 μs+10%(@1kHz) | Not displayed | Similar Note5 | | --- | --- | --- | --- | --- | --- | | Net Charge (μC per pulsetrain) | 0 | 0 us per pulse train | 0 | 0 μC@500 Ω | Similar Note5 | | Maximum Phase Charge (μC) | 3.3 μC@500 Ω | 5.81 μC@500 Ω | 0.084uC@500 Ω | 0.0774 μC@500 Ω | Similar Note5 | | Maximum Current Density(mA/cm2) | 8.3mA/cm2@500 Ω | 8.8mA/cm2@500 Ω | 0.64 mA/cm2@500 Ω=3.22 mA@1kHz/5.04cm2(area of aelectrode. All 6 electrode of the device are the same size) | 0.4mA/cm2@500 Ω | Similar Note5 | | Maximum Density Power | 2000 μW/cm2, 0.002W/cm2 | 39600 μW/cm2 | I2×R = (0.00322)2×500=0.0052 Watts = 5.2mW 0.0052/5.04 = 0.0010W/ cm2 | 0.26mW/cm2@500 Ω | Similar Note5 | | Burst Per Second | 300 μs | 30 pulses | Not displayed | Not displayed | Similar Note5 | | Burst Duration | 300 μs | 2740~3400 | Not displayed | Not displayed | Similar Note5 | | ON Time (seconds) | 0.2 to 16 seconds (Depending on the pattern of output and the intensity level) | 0.63~0.80 | 0.2 to 16 seconds (Depending on the pattern of output and the intensity level) | Not displayed | Similar Note5 | | Electrode size | There are 12 small electrode and 4 big electrode electrode. Small electrode: 0.65cm2±10% Big electrode: 2.55cm2±10% | 9 / 8.8= 1.02 cm2 | 5.04cm2 | 32 / 0.4= 80 cm2 | Similar Note5 | | Treatment time | 1.Red light + Near-Infrared light: 10 minutes 2.Red light + Amber light + Dark Red light + Deep Near-Infrared light: 10 minutes 3.Dark Red light + Deep | 10 minutes only | 10 minutes only | 10 minutes | Same | Guangdong Newdermo Biotech Co.,Ltd 7/14 {11} Traditional 510(k) Submission of LED Light Therapy Mask | | Near-Infrared light: 10 minutes 4.Blue light: 3 minutes 5.Pulse mode: 10 minutes | | | | | | --- | --- | --- | --- | --- | --- | | Safety and EMC | ANSI/AAMI ES 60601-1; IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-10 IEC 60601-2-83 IEC 62471 | ANSI/AAMI ES 60601-1; IEC 60601-1-2 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC60601-2-10 | IEC 60601-1 IEC60601-1-11 IEC 60601-1-2 IEC60601-2-10 IEC 62133-2 | Same | # Note1 Although the Subject Device's Product Code includes all Product Codes of the Predicate/Reference Devices, this variation has no impact on safety. # Note2 Although the Subject Device has a broader Intended Use, it is entirely derived from the Intended Uses of the Predicate/Reference Devices; therefore, this difference raises no safety concerns. # Note3 Although the power supply of the Subject Device is not identical to that of the Predicate/Reference Devices, both have passed EMC and safety compliance testing; therefore, this difference raises no safety concerns. # Note4 Although the battery of the Subject Device is not identical to that of the Predicate/Reference Devices, both utilize lithium batteries and have passed safety and EMC testing; therefore, this difference raises no safety concerns. # Note5 Although the performance requirements of the Subject Device are not identical to those of the Predicate/Reference Devices, its output voltage and current are lower than those of the Predicate/Reference Devices. Furthermore, as it has passed IEC 60601-2-10 testing, this difference raises no safety concerns. Guangdong Newdermo Biotech Co.,Ltd 8/14 {12} Traditional 510(k) Submission of LED Light Therapy Mask Comparison Table for Product Code OHS & OLP | Item | Subject Device | Predicate device2 | Predicate device3 | Predicate device4 | Predicate device5 | Comparison Result | | --- | --- | --- | --- | --- | --- | --- | | Trade name | LED Light Therapy Masks | Q-Rejuvalight Pro Facewear (Model: P19-0023) | Shani Darden LED light therapy mas | Wrinkle Treatment Device (JM2) | TheraFace Mask | / | | 510 (k) number | K261370 | K230042 | K214103 | K240360 | K230293 | / | | Manufacturer | Guangdong Newdermo Biotech Co., Ltd. | Light Tree Ventures Europe B.V. | Harpar Grace Internationa | Shenzhen Qianyu Technology Co., Ltd. | Schiff & Company, Inc. | / | | Regulation number | 21 CFR 882.5890 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810, | Same | | Regulation Name | Stimulator, Transcutaneous Electrical, Aesthetic Purposes; Light Based Over The Counter Wrinkle Reduction; Over-The-Counter Powered Light Based Laser For Acne | Light Based Over The Counter Wrinkle Reduction Over-The-Counter Powered Light Based Laser For Acne | Light Based Over The Counter Wrinkle Reduction, Over-The-Counter Powered Light Based Laser For Acne | Light Based Over The Counter Wrinkle Reduction | Light Based Over The Counter Wrinkle Reduction, Over-The-Counter Powered Light Based Laser For Acne | Similar Note6 | | Product code | NFO, OHS, OLP | OHS, OLP | OHS, OLP | OHS | OHS, OLP | Similar Note6 | | Classification | II | II | II | II | II | Same | | Indications for use/ Intended use | 1.Red light + Near-Infrared light: Intended for treat full face wrinkles; 2.Red light + Amber light + Dark Red light + Deep Near-Infrared light: Intended for treat full face wrinkles; | Treatment of wrinkles and mild to moderate inflammatory acne | The Shani Darden LED light therapy mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris | The wrinkle treatment device (model: JM2) is an Over-The-Counter (OTC) light based device intended for the use in treating full-face wrinkles. | The device can work in multiple modes as described below, with the corresponding indications for use: Red Light is intended to treat full face wrinkles Blue Light is | Similar Note7 | Guangdong Newdermo Biotech Co.,Ltd 9 / 14 {13} Traditional 510(k) Submission of LED Light Therapy Mask | | 3.Dark Red light + Deep Near-Infrared light: Intended for treat full face wrinkles; 4.Blue light: Intended for treatment of mild to moderate inflammatory acne; 5.The Pulse mode is indicated for facial stimulation. | | of the face. The Shani Darden LED light therapy mask is an over-the-counter device intended to emit energy in the red and near infra-red spectrum and is intended for the use in the treatment of full-face wrinkles. | | intended to treat mild to moderate inflammatory acne Red + Infrared Light is intended to treat full face wrinkles. | | | --- | --- | --- | --- | --- | --- | --- | | Location for use | Face | Face | Face | Face | Face | Same | | OTC or prescription | OTC | OTC | OTC | OTC | OTC | Same | | Power supply | Input:DC 5.0V , 1A; Li-ion Polymer Battery: DC 3.7V, 2000mAh, 7.4Wh | Input: 5V, 2A Battery: 3.7V, 600mAh | Electrical Input to power adaptor: 100v-240v.50/60Hz. Rated at 0.7A.Electrical Output from power adaptor: 12V, 1A | Not display | 5-15V DC 2.5A max powered by 2 Lion Batteries 3.7 V 1500mAh ) is charged via Universal USB charger cord or fast charger adaptor | Similar Note8 | | Power Source | Lithium-Ion Battery (rechargeable) | Lithium-Ion Battery | Battery or Universal USB power source | Lithium-Ion Battery (rechargeable) | Battery or Universal USB power source | Similar Note9 | | Light source | LED | LED | LED | LED | LED | same | | Wavelengths | 605nm, 630nm, 660nm, 830nm 850nm 415nm | 605nm, 630nm, 660nm, 880nm, 415nm | 630nm ± 10nm 830nm ± 10nm 415nm ± 10nm | 660 ± 20nm 850 ± 20nm | 633nm ± 10nm 830nm ± 10nm 415nm ± 10nm | Similar Note10 | | Power Density | M1-Red light (630 nm) + Near-Infrared light (830 nm): 29 mW/cm^{2}; M2- Red light | Single wavelength: 605nm:15+5mW/cm^{2} 630nm:20+5mW/cm^{2} 660nm:25+5mW/cm^{2} 880nm:10+5mW/cm^{2} | M1-Blue light (415nm) + Red light (630nm): 44mW/cm^{2} M2-Red light (630nm) + Near-Infrared light | 40/70/100mW/cm^{2} | M1-Red light (633nm) : 73mW/cm^{2} ± 5mW/cm^{2} M2-Blue light (415nm): 64mW/cm | Similar Note10 | Guangdong Newdermo Biotech Co.,Ltd 10 / 14 {14} Traditional 510(k) Submission of LED Light Therapy Mask | | (630nm) + Amber light (605 nm) +Dark Red light (660 nm) +Deep Near-Infrared light (880 nm): 21 mW/cm²; M3-Dark Red light (660 nm) + Deep Near-Infrared light (850 nm): 40 mW/cm²; M4-Blue light (415 nm): 64 mW/cm². | 415nm:25+5mW/cm² Total:70mW/cm²(wrinkle) 45mW/cm²(acne) | (830nm): 29mW/cm² | | ² ± 5mW/cm² M3-Red light (633nm) + Near-Infrared light (830nm): 73mW/cm² ± 5mW/cm² /55mW/cm² ± 5mW/cm² | | | --- | --- | --- | --- | --- | --- | --- | | Treatment time | 1.Red light + Near-Infrared light: 10 minutes 2.Red light + Amber light + Dark Red light + Deep Near-Infrared light: 10 minutes 3.Dark Red light + Deep Near-Infrared light: 10 minutes 4.Blue light: 3 minutes 5.Pulse mode: 10 minutes | 3 minutes per treatment | 10 minutes per treatment | Not displayed | LED: 3 minutes each light mode for a total of 9 minutes per treatment, recommended to use 2 to 5 times per week. | Similar Not10 | | Safety and EMC | ANSI/AAMI ES 60601-1; IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-10 IEC 60601-2-83 IEC 62471 | IEC 60601-1; IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-57 IEC 62133-2 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 60825-1 | IEC 60601-1; IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-57 IEC 62471 | Similar Note11 | Comparison in Detail(s): Note6 Although the Subject Device's Product Code includes all Product Codes of the Predicate/Reference Devices, this variation has no impact on safety. Guangdong Newdermo Biotech Co.,Ltd 11/14 {15} Traditional 510(k) Submission of LED Light Therapy Mask # Note7 Although the Subject Device has a broader Intended Use, it is entirely derived from the Intended Uses of the Predicate/Reference Devices; therefore, this difference raises no safety concerns. # Note8 Although the power supply of the Subject Device is not identical to that of the Predicate/Reference Devices, both have passed EMC and safety compliance testing; therefore, this difference raises no safety concerns. # Note9 Although the battery of the Subject Device is not identical to that of the Predicate/Reference Devices, both utilize lithium batteries and have passed safety and EMC testing; therefore, this difference raises no safety concerns. # Note10 The Predictive device and the Reference device have fully covered the wavelengths of the Subject device. This slight difference will not raise safety and effective issue. 1. The Red light and Near-Infrared light(630+830nm, 29mW/cm², 10mins) as same as the Red light and Near-Infrared light(630nm+830nm, 29mW/cm², 10mins) of the Predicate device3. So, it will not raise safety and effective issue 2. The Red light + Amber light + Dark Red light + Deep Near-Infrared light (630 nm + 605 nm + 660 nm + 880 nm, 21mW/cm², 10mins) of the subject device's total power density(21×10×60÷1000=12.6J/cm²) is as same as the light (630 nm + 605 nm + 660 nm + 880 nm, 70mW/cm², 3minutes, 70×3×60÷1000=12.6J/cm²)of the Predicate device2. So, it will not raise safety and effective issue. 3. The Red light and Near-Infrared light(660+850nm, 40mW/cm², 10mins) is close to the Predicate device4(660+850nm, 40/70/100mW/cm², not display). So, it will not raise safety and effective issue. 4. The Blue light (415nm, 64mW/cm², 3mins) is as same as the Predicate device5(415nm, 64mW/cm², 3mins). So, it will not raise safety and effective issue. # Note11 The subject device complies with more laws, making it safer compared to the predicate device. All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion. Guangdong Newdermo Biotech Co.,Ltd 12 / 14 {16} Traditional 510(k) Submission of LED Light Therapy Mask ## 10. Performance Data: ### Non-clinical data: Non-clinical tests have been conducted to verify that the LED Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device complies with the following standards: ➤ ANSI AAMI ES 60601-1:2005/AMD1:2012/AMD2:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ➤ IEC 60601-1-2:2014+A1:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances – Requirements and tests ➤ IEC/TR 60601-4-2:2024 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems ➤ IEC 60601-1-11:2015/AMD1:2020, 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 60601-2-10:2012/AMD2:2023 Amendment 2 - Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators ➤ IEC 60601-2-83:2019 Medical electrical equipment - Part 2-83: Particular requirements for the basicsafety and essential performance of home light therapy equipment ➤ IEC 62133-2:2017/AMD1:2021 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 62471:2016 Photobiological safety of lamps and lamp systems ### Biocompatibility Test The device has been tested for biocompatibility, it complies with the following standards. ➤ 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: Tests for Irritation and Skin Sensitization Guangdong Newdermo Biotech Co.,Ltd 13 / 14 {17} Traditional 510(k) Submission of LED Light Therapy Mask ➤ ISO 10993-23:2021, Biological Evaluation of Medical Devices - Part 23: Tests for irritation # Software Verification and Validation Testing Software verification and 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.” Clinical data: Not applicable. # Summary Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device. # 11. Conclusion The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that LED Light Therapy Mask should perform as intended in the specified use conditions, and all the data demonstrate that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use. The subject device LED Light Therapy Mask is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K243587, K220198, K214103, K230042, K240360, K230293, K252146. Guangdong Newdermo Biotech Co.,Ltd 14 / 14