Who is the manufacturer of LED light therapy mask (FM-01, FM-02, FM-03)?

Guangdong Newdermo Biotech Co., Ltd. filed the 510(k) submission for LED light therapy mask (FM-01, FM-02, FM-03) (K223544).

What is the FDA product code for LED light therapy mask (FM-01, FM-02, FM-03)?

OHS. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for LED light therapy mask (FM-01, FM-02, FM-03)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for LED light therapy mask (FM-01, FM-02, FM-03)?

LED FACIAL LIGHT THERAPY MASK, FLEXIBLE LED LIGHT THERAPY (K200983); Beauty LED Mask (K221151); RED Light Device (K162489); TheraFace LED (K212155).

Who can help prepare an FDA 510(k) submission like LED light therapy mask (FM-01, FM-02, FM-03)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LED light therapy mask (FM-01, FM-02, FM-03)

K223544 · Guangdong Newdermo Biotech Co., Ltd. · OHS · Feb 23, 2023 · General, Plastic Surgery

Device Facts

Record ID	K223544
Device Name	LED light therapy mask (FM-01, FM-02, FM-03)
Applicant	Guangdong Newdermo Biotech Co., Ltd.
Product Code	OHS · General, Plastic Surgery
Decision Date	Feb 23, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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; for the temporary relief of minor muscle and joint pain, 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.

Device Story

Wearable LED phototherapy mask (models FM-01, FM-02, FM-03) for home use. Device consists of mask, controller, adapter, USB cable, and straps. Emits red (620nm), blue (460nm), infrared (850nm), or mixed light. User operates device via controller to select light mode for skin treatment or topical heating. Output is light energy delivered to face/body. Healthcare provider does not operate; patient self-administers. Benefits include wrinkle reduction, acne treatment, and muscle pain relief. Device transforms electrical input into therapeutic light output. Safety verified via electrical and biocompatibility testing.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-57. Biocompatibility testing per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Wearable LED mask. Light source: LED. Wavelengths: Red (620nm), Blue (460nm), Infrared (850nm), Mixed. Intensity: 2.0-12.0 mW/cm². Power: 100-240V AC input, 5V DC output. Biocompatible materials per ISO 10993. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57.

Indications for Use

Indicated for treatment of full-face wrinkles (red light), mild to moderate inflammatory acne (blue/mixed light), and topical heating for temporary relief of minor muscle/joint pain, arthritis, muscle spasm, stiffness, and increased local blood circulation (infrared light). Intended for OTC home use.

Regulatory Classification

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 FACIAL LIGHT THERAPY MASK, FLEXIBLE LED LIGHT THERAPY (K200983)
Beauty LED Mask (K221151)
RED Light Device (K162489)
TheraFace LED (K212155)

Reference Devices

LED Light Therapy Device, KN-7000L (K222751)

Related Devices

K253400 — LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) · Shenzhen Saidi Light Therapy Technology Co., Ltd. · Dec 24, 2025
K242385 — LED Therapy Mask (MN1, M226) · Shenzhen Borria Technology Co., Ltd. · Apr 7, 2025
K252093 — Light Therapy Mask (1019055) · Merchsource, LLC · Oct 16, 2025
K253712 — LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) · Shenzhen Rainbow Technology Co., Ltd. · Jan 23, 2026
K221775 — LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) · Light Tree Ventures Europe B.V. · Dec 20, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font. February 23, 2023 Guangdong Newdermo Biotech Co.,Ltd Annie Cai Certificate Engineer Building C28. Huachuang Industrial Park, Jinshan Avenue Shiji Town, Panyu Guangzhou. 511450 China Re: K223544 Trade/Device Name: LED light therapy mask (FM-01, FM-02, FM-03) 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, ILY Dated: November 24, 2022 Received: November 25, 2022 Dear Annie Cai: 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 (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 located 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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. # Jianting Wang -S Jianting Wang Acting 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K223544 Device Name LED light therapy mask (FM-01, FM-02, FM-03) Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) | For activities identified in 37.44, Subpart D | <div> <input type="checkbox"/> </div> | |---------------------------------------------------|--------------------------------------------------| | For Streamlined permitting under 37.44, Subpart C | <div> <input checked="" type="checkbox"/> </div> | | | Prescription Use (Part 21 CFR 801 Subpart D) |X | 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." {3}------------------------------------------------ ## 510(K) Summary K223544 {4}------------------------------------------------ # 510 (K) Summary ## 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 | |---------------------------------------|------------------------------------------------------------------------------------------------------------------| | Address: | Building C28. Huachuang Industrial Park Jinshan Avenue, Shiji Town, Panyu, Guangzhou, 511450 P.R. China | | Tel: | +86(020) 31105688 | | Contact person: | Annie Cai | | Email: | caidejiao@qq.com | | Preparing date: | February 22, 2023 | | 2. Device name and classification: | | | Device Name: | LED light therapy mask | | Model: | FM-01, FM-02, FM-03 | | Classification Name/ Product code: | 21 CFR 878.4810 OHS 21 CFR 878.4810 OLP 21 CFR 890.5500 ILY | | Regulatory Class: | Class II | ## 3.Premarket Notification Class III Certification and Summary Not applicable, the subject device is Class II. #### 4. Predicate Device(s): #### 1) Predicate device1 | Sponsor: | NINGBO HESI ELECTRIC CO., LTD | |----------------------|--------------------------------------------------------------| | Device name: | LED FACIAL LIGHT THERAPY MASK, FLEXIBLE LED LIGHT THERAPY | | 510(k) Number: | K200983 | | Product Code: | OHS, OLP, ILY | | 2) Predicate device2 | | | Sponsor: | Hunan Guangye Biotechnology Co., Ltd. | | Device name: | Beauty LED Mask | {5}------------------------------------------------ Traditional 510(k) Submission of LED light therapy mask | 510(k) Number: | K221151 | |----------------------|------------------------------------------------------| | Product Code: | OHS, OLP | | 3) Predicate device3 | | | Sponsor: | Zhongshan Bisen Plastic Electronic Products Co.,Ltd. | | Device name: | RED Light Device | | 510(k) Number: | K162489 | | Product Code: | OHS | | 4) Predicate device4 | | | Sponsor: | Theragun, Inc. | | Device name: | TheraFace LED | | 510(k) Number: | K212155 | | Product Code: | OHS, OLP | | 5) Reference device | | | Sponsor: | Xuzhou Kernel Medical Equipment Co., Ltd. | | Device name: | LED Light Therapy Device, KN-7000L | | 510(k) Number: | K222751 | | Product Code: | GEX | #### 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: LED light therapy mask is a home use wearable LED phototherapy device which can help solve various skin problems. LED light therapy mask is consisting of mask, controller, adapter, USB cable and straps. There are 4 kinds of light which include Red light (wavelength 620mm), Blue light (wavelength 460nm), Infrared light (wavelength 850mm), Mixed light (wavelength 620mm and 850nm and 460nm). #### 8. Intended Use: Red light: Treatment of full-face wrinkles. Blue light: Treatment of mild to moderate inflammatory acne. {6}------------------------------------------------ Infrared light: Provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, 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. | Item | Subject Device | Predicate device1(K200983) | Predicate Device2(K221151) | Comparison Result | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------| | Trade name | LED light therapy mask | LED FACIAL LIGHT THERAPY MASK, FLEXIBLE LED LIGHT THERAPY | Beauty LED Mask | / | | 510 (k) number | K223544 | K200983 | K221151 | / | | Manufacturer | Guangdong Newdermo Biotech Co.,Ltd | NINGBO HESI ELECTRIC CO., LTD | Hunan Guangye Biotechnology Co., Ltd. | / | | Regulation number | 21 CFR 878.4810 21 CFR 890.5500 | 21 CFR 878.4810, 21 CFR 890.5500 | 21 CFR 878.4810 | Same | | Regulation Name | Light Based Over The Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP), Infrared, Therapeutic Heating(ILY) | Light Based Over The Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP), Lamp, Infrared, Therapeutic Heating(ILY) | Light Based Over The Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP) | Same | | Product code | OHS, OLP, ILY | OHS, OLP, ILY | OHS, OLP | Same | | Classification | II | II | II | Same | | Indications for use/ Intended use | Red light: Treatment of full-face wrinkles. Blue light: Treatment of mild to moderate inflammatory acne. | The LED FACIAL LIGHT THERAPY MASK (Model: HK207) is intended to: The device | The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne. | Similar Note2 | #### 9. Predicate Device Comparison {7}------------------------------------------------ | 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. | emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris. - The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face wrinkles. The FLEXIBLE LED LIGHT THERAPY (Model: HK209) is intended to: - The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris. - The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face wrinkles. - The device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| {8}------------------------------------------------ | | | the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. | | | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------| | Location for use | Face and body | Entire Face and body | Face | Same | | OTC or prescription | OTC | OTC | OTC | Same | | Power supply | Input: 100-240 V~, 50/60 Hz, 0,25 A Output: DC 5 V, 500 mA | Input: 100 – 240Vac, 2.0 A, 50/60Hz | Input: 100 -240 V ~ 50 /60 Hz Output: 5V 1A | Similar Note4 | | Light source | LED | LED | LED | same | | Wavelength | Red: 620nm Blue: 460nm Infrared: 850nm Mixed: 620nm and 850nm and 460nm | 465nm, 640nm, 880nm | Red (637nm±5nm) and IR (854nm±5nm); Blue (465±5nm) | Compare with predicate device 4 Similar Note 5 | | LED Intensity | Red light: 2.0~3.0 mW/cm² Blue light:2.0~4.0 mW/cm² Infrared light: 2.0~4.0 mW/cm² Mixed light: 9.0~12.0 mW/cm² | 6.5 mW/cm² | Red+IR: 25.5mW/cm² Blue: 1.36mW/cm² | Similar Note6 | | Treatment time | Manual Mode: 15minutes each time, Automatic Mode: 10minutes each time. 3-4 treatment a week, reduce to 1-2 | 3 times a week for 30 min. 4 weeks | 10min each time | Compare with predicate device 3 Similar Note7 | | | treatment a week once the results shown. | | | | | Dimensions (mm) | FM-01: 207X277X43mm, FM-02: 198X383X33.5mm, FM-03: 237.5X108X8.1mm | Not public | LED Mask: Approximately 183 mm x 238 mm x 98 mm Controller: 100mm x 50 mm x 21.5 mm | / | | Electrical safety | IEC 60601-1; IEC 60601-1-2 | IEC 60601-1; IEC 60601-1-2 | IEC 60601-1; IEC 60601-1-2 | Same | | Biocompatibility feature | All body-contacting materials are complied with ISO10993-5 and ISO 10993-10 | All body-contacting materials are complied with ISO10993-5 and ISO 10993-10 | All body-contacting materials are complied with ISO10993-5 and ISO 10993-10 | Same | {9}------------------------------------------------ | Item | Subject Device | Predicate device3(K162489) | Predicate Device4(K212155) | Comparison Result | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------| | Trade name | LED light therapy mask | RED Light Device | TheraFace LED | / | | 510 (k) number | K223544 | K162489 | K212155 | / | | Manufacturer | Guangdong Newdermo Biotech Co.,Ltd | Zhongshan Bisen Plastic Electronic Products Co.,Ltd. | Theragun, Inc. | / | | Regulation number | 21 CFR 878.4810, 21 CFR 890.5500 | 21 CFR 878.4810 | 21 CFR 878.4810 | Similar Note1 | | Regulation Name | Light Based Over The Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP), Infrared, Therapeutic Heating(ILY) | Light Based Over The Counter Wrinkle Reduction(OHS), | Light Based Over The Counter Wrinkle Reduction(OHS), | Similar Note1 | | Product code | OHS, OLP, ILY | OHS | OHS, OLP | Similar Note1 | | Classification | II | II | II | Same | | Indications for use/ Intended use | Red light: | The RED Light Device is an OTC device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. | 1) The red light is intended to treat periorbital wrinkles. 2) The blue light is intended to treat mild to moderate inflammatory acne. 3) The Red + IR is intended to treat periorbital wrinkles. | Similar Note2 | | 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. | | | | | | Location for use | Face and body | / | Face | Similar Note3 | | OTC or prescription | OTC | OTC | OTC | Same | | Power supply | Input: 100-240 V~, 50/60 Hz, 0,25 A Output: DC 5 V, 500 mA | Adaptor:100~240V AC 50/60Hz Lithium battery: 2x3.7V | Lithium battery :2x3.7V | Similar Note4 | | Light source | LED | LED | LED | Same | | Wavelength | Red: 620nm Blue: 460nm Infrared: 850nm Mixed: 620nm and 850nm and 460nm | Red: 633 ±5nm Infrared: 830 ±5nm | Red light: 633nm±10nm Blue light: 415nm±10nm Red+IR: 633±10nm / 830nm±10nm | Compare with predicate device 4 Similar Note 5 | | LED Intensity | Red light: 2.0~3.0 | 125 mW/cm² | Red light 73±5 | Compare with | | | Blue light:2.0~4.0 mW/cm² Infrared light: 2.0~4.0 mW/cm² Mixed light: 9.0~12.0 mW/cm² | nm); 55 mW/cm² (830nm) | Blue light 64±5 mW/cm² Red+IR: 73±5/55±5 mW/cm² | predicate device 3 Similar Note6 | | Treatment time | Manual Mode: 15minutes each time, Automatic Mode: 10minutes each time. 3-4 treatment a week, reduce to 1-2 treatment a week once the results shown. | For the first month (4 weeks), treatment should be performed 3 times a week for 15-20 minutes each time.(5-7 minutes on each treatment zone). | Red light: 5 - 7 minutes per treatment zone Blue: 5-7 minutes per treatment zone Red+IR: 5-7 minutes per treatment zone | Compare with predicate device 3 Similar Note7 | | Dimensions (mm) | FM-01: 207X277X43mm, FM-02: 198X383X33.5mm, FM-03: 237.5X108X8.1mm | / | / | / | | Electrical safety | IEC 60601-1; IEC 60601-1-2 | IEC 60601-1; IEC 60601-1-2 | IEC 60601-1; IEC 60601-1-2 | Same | | Biocompatibility feature | All body-contacting materials are complied with ISO10993-5 and ISO 10993-10 | All body-contacting materials are complied with ISO10993-5 and ISO 10993-10 | All body-contacting materials are complied with ISO10993-5 and ISO 10993-10 | Same | Guangdong Newdermo Biotech Co.,Ltd {10}------------------------------------------------ {11}------------------------------------------------ Comparison in Detail(s): Note1 The Regulation number, Regulation Name, Product code of predicate1 are not identical to the subject device, all these device are process similar intended use and use very similar light wavelengths to get the intended purpose. This slight deference will not raise safety and effective issue. Note2 The Indications for use/ Intended use of Red light, Blue light , Infrared light of the subject device is the same as that of primary device K200983. The Indications for use/ Intended use of mixed light of the subject device is the same as that of secondary device K221151. {12}------------------------------------------------ #### Note3 The treatment location of the subject device is the same as the predicate device K200983 but identical the other predicate device. The difference in applicable location will not raise safety and effective issue. #### Note4 The power supply of devices are very similar but not identical, the IEC60601-1test demonstrated the safety of the power adapter. The slight difference will not raise safety and effective issue. Note5 The light wavelength is very similar but not identical. The subject device emits blue light, red light and IR light. In the mixed light mode, the subject device emits blue light, IR light simultaneously, while the reference device K222751 can emit red, blue, IR light simultaneously and it has been demonstrated that emit three lights simultaneously is safe and effect. Besides, the subject device has passed IEC60601-2-57 test, the slight difference will not raise safety and effective issue. #### Note6 The LED Intensity of these devices are different, and the LED intensity of the subject device is low and subject device has passed IEC60601-2-57 test, the slight difference will not raise safety and effective issue. #### Note7 The treatment time of these devices are very similar but not identical, treatment is one of the factors to get the intended purpose. What's more, the subject device has IEC60601-1, IEC60601-2-57 test, the slight difference will not raise safety and effective issue. 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 product come into conclusion. #### 10. Performance Data: #### Non-clinical data: Non-clinical tests have been conducted to verify that the Beauty 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, Medical electrical equipment Part 1: General A requirements for basic safety and essential performance - A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests - > IEC 60601-1-11, 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 {13}------------------------------------------------ - IEC 60601-2-57, Medical Electrical Equipment Part 2-57: Particular requirements A for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use #### Biocompatibility Test The device has been tested for biocompatibility; it complies with the following standards. - > ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity - A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization. #### 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. In other words, the subject device (LED light therapy mask) is Substantial Equivalent to the predicate devices K200983, K221151, K162489 and K212155.