(90 days)
The LED Light Therapy Mask (Model: FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
FCM902, FCM905, FCM906, FCM908:
a.Red light: Treatment of full-face wrinkles.
b.Blue+Infrared light: Treatment of mild to moderate inflammatory acne.
c.Yellow+Infrared light: Treatment of full-face wrinkles.
11-001-RBMASK:
a.Red+Infrared light: Treatment of full-face wrinkles.
b.Blue light: Treatment of mild to moderate inflammatory acne.
FCM910:
a.Red+Infrared light: Treatment of full-face wrinkles.
b.Blue light: Treatment of mild to moderate inflammatory acne.
c.Yellow+Infrared light: Treatment of full-face wrinkles.
The LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) adopts light emitting diodes (LED) in the red (630nm ±5nm) , infrared (880nm±5nm) and blue (415±5nm) spectrum to irradiate on the face to realize its therapeutic effect.
For FCM902, FCM905, FCM906, FCM908 and FCM910, it also contain yellow (590±5nm) spectrum and green (520±5nm) spectrum.
The LED Light Therapy Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, LED Light Therapy Mask has incorporated protective eye-shield which blocks light energy from LEDs.
a. Red light: Treatment of full-face wrinkles.
b. Blue+Infrared light: Treatment of mild to moderate inflammatory acne.
c. Yellow+Infrared light: Treatment of full-face wrinkles.
d. Green Light: light in wavelength 520nm(±5nm). Green light makes users feel like they are outside in a green world, which may make users relax, which has no medical therapeutic effect.
e. Red+Infrared light: Treatment of full-face wrinkles.
f. Blue light: Treatment of mild to moderate inflammatory acne.
The provided FDA 510(k) Clearance Letter concerns an LED Light Therapy Mask for treating wrinkles and mild to moderate inflammatory acne. However, this document is a clearance letter and a 510(k) summary, not a clinical study report. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing.
Therefore, the document does NOT contain the details required to answer many of the specific questions about acceptance criteria and the study that proves the device meets those criteria, particularly those related to clinical performance, human reader studies, or expert ground truth.
The information provided is mostly about device specifications, comparison to predicates, and compliance with non-clinical safety standards (electrical safety, biocompatibility, photobiological safety). It states that "Non-clinical testings have been conducted to verify that the LED Light Therapy Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device."
Based on the provided text, I can only address what is explicitly mentioned or can be reasonably inferred. Most of the questions below would require a separate clinical study report, which is not part of this 510(k) summary.
Acceptance Criteria and Device Performance (Based only on the provided 510(k) Summary):
The acceptance criteria for this device, as inferred from the 510(k) summary, are primarily centered around Substantial Equivalence (SE) to legally marketed predicate devices for the specified indications for use, and compliance with relevant safety and performance standards for an OTC device. The "performance" reported is largely in terms of meeting these technical and safety standards, rather than clinical efficacy metrics from a new human study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Inferred) | Specific Acceptance Criteria (Inferred from 510(k)) | Reported Device Performance and Evidence |
|---|---|---|
| Intended Use | Device intended for "Treatment of wrinkles and mild to moderate inflammatory acne" as an Over-the-Counter (OTC) device. | Meets: Explicitly stated in "Indications for Use" and "Description/Design of device." Directly compared to predicate devices with similar indications. (Ref: Page 7, 9) |
| Technological Characteristics | Similar light source (LEDs), wavelengths, and general operational principles as predicate devices. | Meets: "The LED Light Therapy Mask . . . adopts light emitting diodes (LED) . . . to irradiate on the face to realize its therapeutic effect." Extensive comparison table shows similar wavelengths, light source, and location for use (face). (Ref: Page 7, 10-14) |
| Safety - Electrical | Compliance with general requirements for basic safety and essential performance of medical electrical equipment. | Meets: Passed IEC 60601-1, IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-1-11 (Home healthcare environment). "The power adapter has been assessed for electrical safety along with the main unit." (Ref: Page 15, 16) |
| Safety - Photobiological | Compliance with photobiological safety standards for lamps and lamp systems. | Meets: Passed IEC 62471 test. (Ref: Page 15, 16) |
| Safety - Device Specific (Light Source) | Compliance with particular requirements for non-laser light source equipment for therapeutic/cosmetic use. | Meets: Passed IEC 60601-2-57 test. (Ref: Page 15, 16) |
| Safety - Battery | Safety requirements for secondary cells and batteries (if applicable). | Meets: Passed IEC 62133-2 test for lithium systems. (Ref: Page 15, 16) |
| Safety - Biocompatibility | Body-contacting materials comply with biocompatibility standards. | Meets: Tested for biocompatibility; complies with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Skin Sensitization), and ISO 10993-23 (Irritation). (Ref: Page 8, 14, 16) |
| Software Validation (if applicable) | Software verification and validation conducted. | Meets: "Software verification and validation test according to the requirements of the FDA 'Guidance for Pre Market Submissions and for Software Contained in Medical Devices'" was conducted. (Ref: Page 16) |
Regarding the study that proves the device meets the acceptance criteria:
Based solely on the provided 510(k) summary, the "study" proving the device meets acceptance criteria appears to be a non-clinical testing program focused on product safety and performance standards for substantial equivalence. There is no mention of a human clinical study, an AI component requiring a test set for diagnostic accuracy, or experts establishing ground truth in a clinical context within this document.
Therefore, I cannot provide answers for many of the following questions as the requested information is not present in the provided text.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The document describes non-clinical testing of the device itself (electrical, photobiological, biocompatibility, software V&V), not a clinical test set from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. There is no mention of a test set requiring expert-established ground truth for performance evaluation in this 510(k) summary. This typically applies to AI/CADe devices or clinical efficacy studies, neither of which are detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Since no clinical test set or expert ground truth process is described, an adjudication method is irrelevant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, not done / Not applicable. This device is an LED light therapy mask, not an AI-assisted diagnostic tool. An MRMC study is completely irrelevant to this type of device and its 510(k) clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no "algorithm only" performance study as this is a physical light therapy device, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided for clinical efficacy. For the non-clinical tests, the "ground truth" would be the specified parameters and limits of the IEC/ISO standards (e.g., maximum allowable leakage current, certified photobiological safety levels, biocompatibility thresholds). There is no mention of a clinical ground truth (e.g., for wrinkle reduction or acne treatment) from a study in this document.
8. The sample size for the training set:
- Not applicable / Not provided. This device is cleared based on substantial equivalence and compliance with non-clinical performance standards. It implies a known or existing mechanism of action (light therapy) rather than a newly developed AI algorithm that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As no training set for an algorithm is mentioned, the method for establishing its ground truth is also not applicable.
FDA 510(k) Clearance Letter - LED Light Therapy Mask
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.0 8 . 0 0
Silver Spring, MD 20993
www.fda.gov
August 21, 2025
Shenzhen Fittop Health Technology Co., Ltd.
℅ Youshan Gong
RA Specialist
Feiying Drug & Medical Consulting Technical Service Group
Rm 2401 Zhenye International Business Center, No. 3101-90
Qianhai Road, Nanshan District
Shenzhen, Guangdong 518052
China
Re: K251588
Trade/Device Name: LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)
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: May 16, 2025
Received: May 23, 2025
Dear Youshan Gong:
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
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K251588 - Youshan Gong Page 2
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" (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-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 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-advicecomprehensive-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-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
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K251588 - Youshan Gong Page 3
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-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,
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.08.21 14:31:03 -04'00'
Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
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): K251588
Device Name: LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)
Indications for Use (Describe)
The LED Light Therapy Mask (Model: FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
FCM902, FCM905, FCM906, FCM908:
- a.Red light: Treatment of full-face wrinkles.
- b.Blue+Infrared light: Treatment of mild to moderate inflammatory acne.
- c.Yellow+Infrared light: Treatment of full-face wrinkles.
11-001-RBMASK:
- a.Red+Infrared light: Treatment of full-face wrinkles.
- b.Blue light: Treatment of mild to moderate inflammatory acne.
FCM910:
- a.Red+Infrared light: Treatment of full-face wrinkles.
- b.Blue light: Treatment of mild to moderate inflammatory acne.
- c.Yellow+Infrared light: Treatment of full-face wrinkles.
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
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"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."
Page 5
510 (k) Summary of K251588
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information:
510(k) owner's name: Shenzhen Fittop Health Technology Co., Ltd.
Address: 3, 6, 8/F, BLDG 3, No.7, LangFeng Road, Xinshi, Community, Dalang, Longhua District, Shenzhen, Guangdong, 518000, China
Contact person: Sandy Lee
Position: Vice president
Phone number: +86-13828835685
Email: info@fittop.com
Contact person: Sandy Lee
Date of summary prepared: 2025-8-19
(2) Reason for the submission
New device, there were no prior submissions for the device.
(3) Proprietary name of the device
Trade name/model: LED Light Therapy Mask/Model: FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910
Regulation name: Light Based Over The Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP), Infrared, Therapeutic Heating(ILY)
Regulation number: 21 CFR 878.4810, 21 CFR 890.5500
Product code: OHS, OLP, ILY
Review panel: General & Plastic Surgery
Regulation class: Class II
(4) Predicate devices
Primary Predicate device 1
| Sponsor | Shenzhen Kaiyan Medical Equipment Co., Ltd |
|---|---|
| Device Name and Model | CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) |
| 510(k) Number | K242593 |
| Product Code | OHS, OLP |
| Regulation Number | 21 CFR 878.4810 |
Page 6
| Regulation Class | II |
|---|
Predicate device 2
| Sponsor | Dongguan Boyuan Intelligent Technology Co., Ltd. |
|---|---|
| Device Name and Model | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) |
| 510(k) Number | K241857 |
| Product Code | OHS, OLP, ILY |
| Regulation Number | 21 CFR 878.4810, 21 CFR 890.5500 |
| Regulation Class | II |
Predicate device 3
| Sponsor | SharkNinja Operating, LLC |
|---|---|
| Device Name and Model | CryoGlow (FW3XXXX) |
| 510(k) Number | K242796 |
| Product Code | OHS, OLP |
| Regulation Number | 21 CFR 878.4810 |
| Regulation Class | II |
Predicate device 4
| Sponsor | Shenzhen SUNGPO HI-TECH Electronic Co.,Ltd |
|---|---|
| Device Name and Model | LED Facial Mask/MZ-01, NEWKEY-01, SP-FM-01 |
| 510(k) Number | K230351 |
| Product Code | OHS, OLP |
| Regulation Number | 21 CFR 878.4810 |
| Regulation Class | II |
Predicate device 5
| Sponsor | Shenzhen Kaiyan Medical Equipment Co., Ltd |
|---|---|
| Device Name and Model | Q-Rejuvalight Pro Facewear (Model: P19-0023) |
| 510(k) Number | K230042 |
| Product Code | OHS, OLP |
| Regulation Number | 21 CFR 878.4810 |
| Regulation Class | II |
(5) Description/ Design of device:
The LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK,
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FCM910) adopts light emitting diodes (LED) in the red (630nm ±5nm) , infrared (880nm±5nm) and blue (415±5nm) spectrum to irradiate on the face to realize its therapeutic effect.
For FCM902, FCM905, FCM906, FCM908 and FCM910, it also contain yellow (590±5nm) spectrum and green (520±5nm) spectrum.
The LED Light Therapy Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, LED Light Therapy Mask has incorporated protective eye-shield which blocks light energy from LEDs.
- a. Red light: Treatment of full-face wrinkles.
- b. Blue+Infrared light: Treatment of mild to moderate inflammatory acne.
- c. Yellow+Infrared light: Treatment of full-face wrinkles.
- d. Green Light: light in wavelength 520nm(±5nm). Green light makes users feel like they are outside in a green world, which may make users relax, which has no medical therapeutic effect.
- e. Red+Infrared light: Treatment of full-face wrinkles.
- f. Blue light: Treatment of mild to moderate inflammatory acne.
(6) Indications for use:
The LED Light Therapy Mask (Model: FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
FCM902, FCM905, FCM906, FCM908:
- a.Red light: Treatment of full-face wrinkles.
- b.Blue+Infrared light: Treatment of mild to moderate inflammatory acne.
- c.Yellow+Infrared light: Treatment of full-face wrinkles.
11-001-RBMASK:
- a.Red+Infrared light: Treatment of full-face wrinkles.
- b.Blue light: Treatment of mild to moderate inflammatory acne.
FCM910:
- a.Red+Infrared light: Treatment of full-face wrinkles.
- b.Blue light: Treatment of mild to moderate inflammatory acne.
- c.Yellow+Infrared light: Treatment of full-face wrinkles.
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(7) Materials
| Component name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| LED Light Therapy Mask (FCM902) | Silicone, ABS, PVC, Metal | Surface-contacting device: Intact skin | Less than 24 hours |
| LED Light Therapy Mask (FCM905, FCM906, FCM908) | Silicone, ABS, Metal, PC | ||
| LED Light Therapy Mask (11-001-RBMASK) | ABS, Silicone, Metal; Belt : Polyamides (PA) | ||
| LED Light Therapy Mask (FCM910) | Silicone, ABS, PC, Metal |
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to "Biocompatibility Discussion".
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(8) Technological characteristics and substantial equivalence:
The LED Light Therapy Mask is intended to use LED light for the treatment of wrinkles and mild to moderate inflammatory acne.
Based on FDA Medical Device Database, we can find its similar devices. And we adopt K242593 as its primary predicate device and K241857, K242796, K230351 and K230042 as its predicate devices. Through the comparisons, we come to a conclusion that these devices have the same intended use, similar technological characteristics and principles of operation.
The details are as follows:
| Item | Subject device K251588 | Primary Predicate device 1 K242593 | Predicate device 2 K241857 | Predicate device 3 K242796 | Predicate device 4 K230351 | Predicate device 5 K230042 | Remark |
|---|---|---|---|---|---|---|---|
| Trade name | LED Light Therapy Mask/ Model: FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910 | CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90N) | LED Light Therapy Device (KFB290, KFB291) | CryoGlow (FW3XXXX) | LED Facial Mask/ MZ-01, NEWKEY01, SP-FM-01 | Q-Rejuvalight Pro Facewear | / |
| 510 (k) number | K251588 | K242593 | K241857 | K242796 | K230351 | K230042 | / |
| Manufacturer | Shenzhen Fittop Health Technology Co., Ltd. | Shenzhen Kaiyan Medical Equipment Co., Ltd | Dongguan Boyuan Intelligent Technology Co., Ltd. | SharkNinja Operating, LLC | Shenzhen SUNGPO HI-TECH Electronic Co.,Ltd | Shenzhen Kaiyan Medical Equipment Co., Ltd | / |
| Regulation number | 21 CFR 878.4810, 21 CFR 890.5500 | 21 CFR 878.4810 | 21 CFR 878.4810, 21 CFR 890.5500 | 21 CFR 878.4810 | 21 CFR 878.4810 | 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) | Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP) | Light Based Over The Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP), Infrared, Therapeutic Heating(ILY) | Light Based Over The Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP) | Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP) | Light Based Over The Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP) | Same |
| Product code | OHS, OLP, ILY | OHS, OLP | OHS, OLP, ILY | OHS, OLP | OHS, OLP | OHS, OLP | Same |
| Class | II | II | II | II | II | II | Same |
| Indications for use/ Intended use | The LED Light Therapy Mask is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne. FCM902, FCM905, FCM906, FCM908: g. Red light: Treatment of full-face wrinkles. h. Blue+Infrared light: Treatment of mild to moderate inflammatory acne. i. Yellow+Infrared light: Treatment of full-face wrinkles. 11-001-RBMASK: a. Red+Infrared light: Treatment of full-face wrinkles. | For MK-90C: The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90C) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris of the face and use in the treatment of full-face wrinkles. For MK-90N: The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90N) is an over the counter device, is | KFB290, KFB291: a. Red light: Treatment of full-face wrinkles. b. 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 | The CryoGlow LED mask emits energy in the red and infrared light spectrum for the treatment of fine lines and wrinkles and in the red, blue, and infrared light spectrum for the treatment of mild-to-moderate inflammatory acne. | LED Facial Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne. | The QRejuvalight Pro Facewear (Model: P19- 0023) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne. | Similar Note 1 |
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| Item | Subject device K251588 | Primary Predicate device 1 K242593 | Predicate device 2 K241857 | Predicate device 3 K242796 | Predicate device 4 K230351 | Predicate device 5 K230042 | Remark |
|---|---|---|---|---|---|---|---|
| b. Blue light: Treatment of mild to moderate inflammatory acne. FCM910: a. Red+Infrared light: Treatment of full-face wrinkles. b. Blue light: Treatment of mild to moderate inflammatory acne. c. Yellow+Infrared light: Treatment of full-face wrinkles. | generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles. | increase local blood circulation. c. Red+Infrared Light: Treatment of full-face wrinkles. d. Amber light: Treatment of full-face wrinkles. e. Blue light: Treatment of mild to moderate inflammatory acne. f. Mixed light(Red+Blue +Infrared): Treatment of mild to moderate inflammatory acne. | |||||
| Location for use | Face | Face | Face | Face | Face | Face | Same |
| OTC or prescription | OTC | OTC | OTC | OTC | OTC | OTC | Same |
| Power supply | Input: 100 -240 V ~ 50 / 60 Hz Li-ion Polymer Battery (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK): 2850mAh Li-ion Polymer Battery (FCM910): 1000mAh | MK-90C and MK-90N: 3.7Vdc, 5200mAh，19.24Wh Lithium battery | Input: 100 -240 V, 50 / 60 Hz Output: 5V, 1A Lithium ion battery: 1300mAh | 2 Li-Ion Batteries 3.6V, 2350 mAh total, charged by USB-A to USB-C charging cord to USB-A charging block | An external adapter Input: AC 100-240V 50-60Hz 0.2A Output: DC 12V 0.5A | Input: 5V, 50/60Hz, 2A Li-ion Polymer Battery: 3.7V, 600mAh, 2.22Wh | Different Note 2 |
| Light source | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) | Same |
| Wavelength | 630nm ±5nm visible red light; 880nm±5nm non-visible red light; 415±5nm blue light; 590±5nm yellow light | MK-90C Mode 1: Red + Infrared (633nm+830nm) Mode 2: Blue + Red (415nm+633nm) Mode 3: Yellow + Infrared (590nm+830nm) MK-90N Mode: Yellow + Infrared (590nm+830nm) | 635nm ± 5nm visible red light; 850nm±5nm Invisible red light; 465±5nm blue light; 605±5nm amber light | 630 ±10nm, 830 ± 10 nm, 415 ±10nm | 625nm±5nm, 465nm±5nm, 605±5nm | 630nm, 880nm, 415nm 605nm, 660nm, | Same |
| LED power | FCM902, FCM905, FCM906, FCM908: 1) "R" (Red) (630nm): low: 25mW/cm², | 415nm: 25±5mW/cm²; 633nm: 20±5mW/cm²; | Red: 25mW/cm² ; IR: 3mW/cm² ; | Skin Sustain: Blue 59.8 ± 7 mW/cm², | Blue:15 | Single wavelength: 605nm: | Similar Note 3 |
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| Item | Subject device K251588 | Primary Predicate device 1 K242593 | Predicate device 2 K241857 | Predicate device 3 K242796 | Predicate device 4 K230351 | Predicate device 5 K230042 | Remark |
|---|---|---|---|---|---|---|---|
| medium: 35mW/cm², high: 40mW/cm² 2) "Y+NIR"(Yellow+NIR) (590nm+880nm) : Yellow: low:5mW/cm², medium: 7mW/cm², high: 10mW/cm²；NIR:10mW/cm² 3) "G"(Green) :(520nm) : low: 3mW/cm², medium: 4mW/cm², high: 5mW/cm² 4) "B+NIR" ("Blue+NIR) :(415nm+880nm) : Blue: low: 15mW/cm², medium: 20mW/cm², high: 25mW/cm²；NIR:10mW/cm² 11-001-RBMASK: 1) "B":(415nm) : low: 15mW/cm², medium:20mW/cm², high: 25mW/cm 2) "R+NIR"(630nm+880nm): Red: low: 15mW/cm², medium: 20mW/cm², high: 25mW/cm²；NIR: 10mW/cm² FCM910: 1) "RED+NIR"(630nm+880nm): Red:low: 15mW/cm², medium: 20mW/cm², high: 25mW/cm²; NIR: 10mW/cm² 2) "YELLOW+NIR" (590nm+880nm): Yellow: low:5mW/cm², medium: 7mW/cm², high: 10mW/cm²；NIR:10mW/cm² 3) "GREEN":(520nm): low: 3mW/cm², medium: 4mW/cm², high: 5mW/cm² 4) "BLUE" :(415nm) : Blue: low: 15mW/cm², medium: 20mW/cm², high: 25mW/cm² | 590nm: 15±5mW/cm²; 830nm: 10±5mW/cm² | Red+IR: 30mW/cm² ; Blue: 18mW/cm² ; Amber: 20mW/cm² ; Mixed light: 9mW/cm² ; | Red 17.0 ± 5mW/cm², IR 51.2 ± 5 mW/cm² Total mode = 128 mW/cm² Skin Clearing [Step 1]: Blue 64 ± 8 mW/cm², IR 64.0 ± 5 mW/cm² Total mode =128 mW/cm² Skin Clearing [Step 2]: Blue 55 ± 6 mW/cm², Red 73 mW/cm² Total mode =128 mW/cm² Skin Clearing [Step 3]: Red 73 mW/cm², IR 55 ± 5mW/cm², Total mode =128 mW/cm² Better Aging: Red 64 ± 5mW/cm², IR 64 ± 5 mW/cm² Total mode = 128 mW/cm² | 15±5mW/cm² | 630nm: 20±5mW/cm² 660nm: 25±5mW/cm² 880nm: 10±5mW/cm² 415nm: 25±5mW/cm² Total: 70mW/cm²(wrinkle)-(605nm+630nm+660nm+880nm) 45mW/cm²(acne)-(630nm+415nm) | ||
| Location for use | Face | Face | Face | Face | Face | Face | Same |
| OTC or prescription | OTC | OTC | OTC | OTC | OTC | OTC | Same |
| Power supply | Input: 100 -240 V ~ 50 / 60 Hz Li-ion Polymer Battery (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK): 2850mAh Li-ion Polymer Battery (FCM910): 1000mAh | MK-90C and MK-90N: 3.7Vdc, 5200mAh，19.24Wh Lithium battery | Input: 100 -240 V, 50 / 60 Hz Output: 5V, 1A Lithium ion battery: 1300mAh | 2 Li-Ion Batteries 3.6V, 2350 mAh total, charged by USB-A to USB-C charging cord to USB-A charging block | An external adapter Input: AC 100-240V 50-60Hz 0.2A Output: DC 12V 0.5A | Input: 5V, 50/60Hz, 2A Li-ion Polymer Battery: 3.7V, 600mAh, 2.22Wh | Different Note 2 |
| Light source | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) | Same |
| Wavelength | 630nm ±5nm visible red light; 880nm±5nm non-visible red light; 415±5nm blue light; 590±5nm yellow light | MK-90C Mode 1: Red + Infrared (633nm+830nm) Mode 2: Blue + Red (415nm+633nm) Mode 3: Yellow + Infrared (590nm+830nm) MK-90N Mode: Yellow + Infrared (590nm+830nm) | 635nm ± 5nm visible red light; 850nm±5nm Invisible red light; 465±5nm blue light; 605±5nm amber light | 630 ±10nm, 830 ± 10 nm, 415 ±10nm | 625nm±5nm, 465nm±5nm, 605±5nm | 630nm, 880nm, 415nm 605nm, 660nm, | Same |
| LED power | FCM902, FCM905, FCM906, FCM908: 1) "R" (Red) (630nm): low: 25mW/cm², | 415nm: 25±5mW/cm²; 633nm: 20±5mW/cm²; | Red: 25mW/cm² ; IR: 3mW/cm² ; | Skin Sustain: Blue 59.8 ± 7 mW/cm², | Blue:15 | Single wavelength: 605nm: | Similar Note 3 |
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| Item | Subject device K251588 | Primary Predicate device 1 K242593 | Predicate device 2 K241857 | Predicate device 3 K242796 | Predicate device 4 K230351 | Predicate device 5 K230042 | Remark |
|---|---|---|---|---|---|---|---|
| Treatment time | FCM902: 3 minutes per treatment for "R", "Y+NIR", "G", "B+NIR" mode. 8 minutes per treatment for "Auto mode". FCM905, FCM906, FCM908: 3 minutes for "Red", "Yellow+NIR", "Green", "Blue+NIR" 11-001-RBMASK: 10 minutes per treatment for "B", "R+NIR" mode. | 10 minutes, Wrinkles: 5 x weekly, 6 weeks Acne: 4 x weekly, 6 weeks | For red, blue and red+infrared: 10, 20, 30 minutes | Skin Sustain: 4.3 min (daily after 8 weeks) Skin Clearing: 8.4 min (daily for at least 8 weeks) Better Aging: 6.4 min(daily for at least 8 weeks) Under-eye cooling: may be used with LED treatments or can be used without LEDs active. Variable | 10 minutes/day, 3 times per week | 3 minutes per treatment | Similar Note 4 |
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| Item | Subject device K251588 | Primary Predicate device 1 K242593 | Predicate device 2 K241857 | Predicate device 3 K242796 | Predicate device 4 K230351 | Predicate device 5 K230042 | Remark |
|---|---|---|---|---|---|---|---|
| medium: 35mW/cm², high: 40mW/cm² 2) "Y+NIR"(Yellow+NIR) (590nm+880nm) : Yellow: low:5mW/cm², medium: 7mW/cm², high: 10mW/cm²；NIR:10mW/cm² 3) "G"(Green) :(520nm) : low: 3mW/cm², medium: 4mW/cm², high: 5mW/cm² 4) "B+NIR" ("Blue+NIR) :(415nm+880nm) : Blue: low: 15mW/cm², medium: 20mW/cm², high: 25mW/cm²；NIR:10mW/cm² 11-001-RBMASK: 1) "B":(415nm) : low: 15mW/cm², medium:20mW/cm², high: 25mW/cm 2) "R+NIR"(630nm+880nm): Red: low: 15mW/cm², medium: 20mW/cm², high: 25mW/cm²；NIR: 10mW/cm² FCM910: 1) "RED+NIR"(630nm+880nm): Red:low: 15mW/cm², medium: 20mW/cm², high: 25mW/cm²; NIR: 10mW/cm² 2) "YELLOW+NIR" (590nm+880nm): Yellow: low:5mW/cm², medium: 7mW/cm², high: 10mW/cm²；NIR:10mW/cm² 3) "GREEN":(520nm): low: 3mW/cm², medium: 4mW/cm², high: 5mW/cm² 4) "BLUE" :(415nm) : Blue: low: 15mW/cm², medium: 20mW/cm², high: 25mW/cm² | 590nm: 15±5mW/cm²; 830nm: 10±5mW/cm² Red+IR: 30mW/cm² ; Blue: 18mW/cm² ; Amber: 20mW/cm² ; Mixed light: 9mW/cm² ; | Red 17.0 ± 5mW/cm², IR 51.2 ± 5 mW/cm² Total mode = 128 mW/cm² Skin Clearing [Step 1]: Blue 64 ± 8 mW/cm², IR 64.0 ± 5 mW/cm² Total mode =128 mW/cm² Skin Clearing [Step 2]: Blue 55 ± 6 mW/cm², Red 73 mW/cm² Total mode =128 mW/cm² Skin Clearing [Step 3]: Red 73 mW/cm², IR 55 ± 5mW/cm², Total mode =128 mW/cm² Better Aging: Red 64 ± 5mW/cm², IR 64 ± 5 mW/cm² Total mode = 128 mW/cm² | 15±5mW/cm² 630nm: 20±5mW/cm² 660nm: 25±5mW/cm² 880nm: 10±5mW/cm² 415nm: 25±5mW/cm² Total: 70mW/cm²(wrinkle)-(605nm+630nm+660nm+880nm) 45mW/cm²(acne)-(630nm+415nm) | ||||
| Treatment time | FCM902: 3 minutes per treatment for "R", "Y+NIR", "G", "B+NIR" mode. 8 minutes per treatment for "Auto mode". FCM905, FCM906, FCM908: 3 minutes for "Red", "Yellow+NIR", "Green", "Blue+NIR" 11-001-RBMASK: 10 minutes per treatment for "B", "R+NIR" mode. | 10 minutes, Wrinkles: 5 x weekly, 6 weeks Acne: 4 x weekly, 6 weeks | For red, blue and red+infrared: 10, 20, 30 minutes | Skin Sustain: 4.3 min (daily after 8 weeks) Skin Clearing: 8.4 min (daily for at least 8 weeks) Better Aging: 6.4 min(daily for at least 8 weeks) Under-eye cooling: may be used with LED treatments or can be used without LEDs active. Variable | 10 minutes/day, 3 times per week | 3 minutes per treatment | Similar Note 4 |
Page 14
| Item | Subject device K251588 | Primary Predicate device 1 K242593 | Predicate device 2 K241857 | Predicate device 3 K242796 | Predicate device 4 K230351 | Predicate device 5 K230042 | Remark |
|---|---|---|---|---|---|---|---|
| FCM910: 3 minutes per treatment for "YELLOW+NIR",''RED+NIR" ,"GREEN", "BULE" mode. 8 minutes per treatment for "Auto mode". | cooling settings are available and may be adjusted by the user. Cooling is intended for refreshing/invigorating/soothing the skin only. | ||||||
| Dimensions (mm) | FCM902: LED Mask: Approximately 2.24 feet x 0.73 feet x 0.08 feet Controller: 0.02 feet x 0.1 feet x 0.35 feet FCM905, FCM906, FCM908: LED Mask: Approximately 2.16 feet x 0.73 feet x 0.12 feet Controller: 0.02 feet x 0.1 feet x 0.35 feet 11-001-RBMASK: LED Mask: Approximately 0.95 feet x 0.73 feet x 0.08 feet Controller: 0.24 feet x 0.24 feet x 0.09 feet FCM910: LED Mask: Approximately 1.94 feet x 0.80 feet x 0.32 feet Controller: 0.26 feet x 0.14 feet x 0.08 feet | No publicly available | KFB290: Approximately 302 mm x 197 mm x 22 mm KFB291: Approximately 412 mm x 195 mm x 22 mm | No publicly available | No publicly available | No publicly available | Different Note 5 |
| Compliance with voluntary standards | IEC 60601-1:2020 IEC 60601-1-2:2020 IEC 60601-1-11:2020 IEC 60601-2-57:2011 IEC 62471:2006 IEC 62133-2:2017 | IEC 60601-1:2005 IEC 60601-1-2:2014 IEC 60601-1-11:2015 IEC 60601-2-57:2023 IEC 62471:2006 IEC 62133-2 | IEC 60601-1:2020 IEC 60601-1-2:2020 IEC 60601-1-11:2020 IEC 60601-2-83:2019 IEC 62471:2006 IEC 62133-2:2017 | IEC 60601-1:2020 IEC 60601-1-2:2020 IEC 60601-1-11:2020 IEC 60601-2-83:2019 IEC 62471:2006 | IEC 60601-1; IEC 60601-1-2; IEC 60601-1-11; IEC 60601-2-57; IEC 62471 | IEC 60601-1; IEC 60601-1-2; IEC 60601-1-11; IEC 60601-2-57; IEC 62471; IEC 62133-2 | Same |
| Biocompatibility feature | ISO 10993-5 ISO 10993-10 ISO 10993-23 | ISO 10993-5 ISO 10993-10 ISO 10993-23 | ISO 10993-5 ISO 10993-10 ISO 10993-23 | ISO 10993-5 ISO 10993-10 ISO 10993-23 | All body-contacting materials are complied with ISO10993-5 and ISO 10993-10 | ISO 10993-5 ISO 10993-10 ISO 10993-23 | Same |
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Comparison in details:
Note 1:
Thought the indication for use of subject device is little different from the predicate devices, the specific description of indication for use can find in predicate devices. Please refer to below table, so this difference should not raise any safety/effectiveness questions.
Note 2:
The power supply for the subject device is different from that of the predicate device, however the lithium battery of the subject device has passed IEC 62133-2 test and the power adapter has been assessed for electrical safety along with the main unit, so this difference should not raise any safety/effectiveness questions.
Note 3:
Although there is little difference of "LED Power" between subject device and predicated devices, both the subject device and predicate device have the same treatment wavelengths (630nm, 880nm, 415nm) and total power density designed in treating the wrinkles and the acne. The subject device has passed the IEC60601-1, IEC60601-1-2, IEC60601-2-57 and IEC62471 test, so the slight difference between the subject device and the predicate device will not raise any safety or effectiveness issues.
Note 4:
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 passed the IEC60601-1, IEC60601-1-2, IEC60601-2-57 and IEC62471 test, the slight difference will not raise safety and effective issue.
Note 5:
Although the appearance, dimensions are different between the subject and predicate device, these differences are insignificant and do not raise any safety/effectiveness problems.
Conclusion:
LED Light Therapy Mask is substantially equivalent to the predicate devices.
Page 16
(9) Non-clinical studies and tests performed:
Non-clinical testings have been conducted to verify that the LED Light Therapy 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:
- IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- 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
- IEC 60601-2-57, 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 62471, Photobiological safety of lamps and lamp systems
- IEC 62133-2, 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
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 InVitro Cytotoxicity
- ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization
- ISO 10993-23, Biological Evaluation of Medical Devices - Part 23: Tests for Irritation
We have also conducted:
- Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
(10) Conclusion
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device LED Light Therapy Mask is as safe, as effective, and performs as well as the legally marketed predicate devices.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.