(85 days)
The Red Light is intended to treat full face wrinkles.
The Blue Light is intended to treat mild to moderate inflammatory acne.
The Yellow Light is intended to treat wrinkles.
The GLAM LED light therapy mask is a home use wearable light emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full face wrinkles and mild to moderate acne of the face. The outer shell of the mask is manufactured from Polyethylene terephthalate (PET). The inner shell is a clear Polycarbonate (PC). The Light emitting diodes are mounted behind the clear Polycarbonate. The LEDs generate the light. The ear hooks are made of Acrylonitrile butadiene styrene (ABS) and the silicone goggle protect the eyes from LED lights. Unfold the ear hooks and place the mask on your face, the mask will automatically activate the light therapy mode. The LEDs produce blue, red and yellow light in the visible spectrum (Blue:415nm +/- 10nm, Yellow: 590nm +/-10nm, Red: 625nm +/-10nm.). The device works by emitting the specified wavelengths to treat full face of wrinkles or to treat mild to moderate inflammatory acne. Press the touch switch on the right ear hook twice to select the light therapy mode you want to use. Each mode operates in a 15-minute cycle. After 15 minutes, the device automatically deactivates the light mode and enters the standby mode.
This FDA 510(k) clearance letter for the GLAM LED Facial Mask (TB-2386F) does not include any information regarding clinical testing, acceptance criteria for device performance related to efficacy (e.g., wrinkle reduction or acne treatment), or studies comparing the device's performance against such criteria.
The letter focuses on the substantial equivalence based on:
- Technological Comparison: Comparing light wavelengths, power density, and treatment time to predicates.
- Safety Standards Compliance: Verification through non-clinical tests (electrical safety, EMC, biocompatibility, photobiological safety, software verification).
Therefore, I cannot provide details on the specific acceptance criteria for efficacy or a study proving the device meets those criteria from the provided document. The 510(k) summary explicitly states: "No animal or clinical study is included in this submission."
However, if we were to hypothesize what acceptance criteria and a study might look like for a device with these indications, and then illustrate what would be missing from this document:
Hypothetical Acceptance Criteria and Performance Study (Not Found in Provided Document):
Since the provided document explicitly states no clinical study was included, the following tables and sections represent what would typically be expected for a device claiming therapeutic efficacy, but none of this information is present in the provided 510(k) clearance letter.
Hypothetical Acceptance Criteria and Reported Device Performance (If Clinical Data Existed)
| Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|
| Red Light (Wrinkle Treatment): | |
| Primary Endpoint: A statistically significant reduction (e.g., >20%) in the appearance of fine lines and wrinkles (e.g., Fitzpatrick Wrinkle Scale, or qualitative dermatological grading) across the full face after 8-12 weeks of treatment, compared to baseline or a control group. | Not reported in 510(k) letter. If available, this section would state the measured percentage reduction in wrinkles, p-values, confidence intervals, and the specific grading scale used. Example: "Mean reduction of 32% in Fitzpatrick Wrinkle Scale scores for fine lines after 10 weeks (p < 0.001, 95% CI: 28-36%)." |
| Secondary Endpoint (e.g., Patient Satisfaction): A statistically significant improvement (e.g., >70% of subjects reporting improvement) in overall skin appearance, texture, or satisfaction as reported by subjects via a validated questionnaire. | Not reported in 510(k) letter. If available, this would include the percentage of satisfied subjects and questionnaire scores. Example: "85% of subjects reported 'moderate' or 'significant' improvement in overall skin appearance (p < 0.001)." |
| Blue Light (Mild to Moderate Inflammatory Acne Treatment): | |
| Primary Endpoint: A statistically significant reduction (e.g., >40%) in the mean number of inflammatory acne lesions (papules, pustules, nodules) on the face after 8-12 weeks of treatment, compared to baseline or a control group. | Not reported in 510(k) letter. If available, this would state the measured percentage reduction in lesion count, p-values, and confidence intervals. Example: "Mean reduction of 55% in inflammatory lesion count after 10 weeks (p < 0.001, 95% CI: 50-60%)." |
| Secondary Endpoint (Investigator Global Assessment - IGA): A statistically significant improvement (e.g., at least a 2-point reduction on a 5-point IGA scale) in at least 70% of subjects. | Not reported in 510(k) letter. If available, this would specify the percentage of subjects achieving the IGA improvement. Example: "75% of subjects achieved at least a 2-point reduction on the IGA scale (p < 0.001)." |
| Yellow Light (Wrinkle Treatment): | |
| Primary Endpoint & Secondary Endpoint: Mirroring the Red Light criteria for wrinkle treatment, demonstrating similar statistically significant reductions or improvements. | Not reported in 510(k) letter. Similar to Red Light, specific efficacy metrics for wrinkle reduction with Yellow Light would be presented here. Example: "Mean reduction of 28% in Fitzpatrick Wrinkle Scale scores for fine lines after 10 weeks (p < 0.001, 95% CI: 24-32%)." |
| Safety Endpoints (Common to all lights): | |
| No serious adverse events (SAEs) related to device use. Incidence of treatment-related adverse events (AEs) such as erythema, dryness, or irritation below a pre-defined threshold (e.g., <10% for mild, <1% for moderate/severe). | Only general safety compliance (IEC standards, biocompatibility) is reported in the 510(k) letter. If clinical data existed, this would list observed AEs. Example: "No SAEs reported. Mild, transient erythema observed in 5% of subjects, resolving within 24 hours. No moderate or severe AEs." |
Details of the Hypothetical Study (Assuming Clinical Data Existed)
As stated, the provided 510(k) summary explicitly states "No animal or clinical study is included in this submission." Therefore, the following are hypothetical details of what such a study would entail, not actual data from this submission.
-
Sample Size and Data Provenance (Hypothetical):
- Sample Size: (e.g., N=150 subjects for efficacy assessment, randomly allocated to device treatment and control groups)
- Data Provenance: (e.g., Prospective, multicenter clinical study conducted in the USA.)
-
Number of Experts and Qualifications for Ground Truth (Hypothetical):
- Number of Experts: (e.g., 3 independent, board-certified dermatologists)
- Qualifications: (e.g., Each dermatologist with at least 10 years of experience in aesthetic dermatology and clinical trials, trained on the specific grading scales used.)
-
Adjudication Method (Hypothetical):
- (e.g., 2+1 consensus: Two experts independently assessed each subject's condition. If their scores differed, a third, senior dermatologist reviewed the case to reach a consensus score. If 2 of 3 agreed, that was the final consensus.)
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Hypothetical):
- Not Applicable: For a direct-to-consumer LED mask, an MRMC study comparing human readers (e.g., radiologists interpreting images) is not relevant. The device directly treats the skin, and efficacy is assessed via clinical observation/photography and patient self-assessment.
-
Standalone Performance (Algorithm Only) (Hypothetical):
- Not Applicable: This device is a physical light therapy device, not an AI software algorithm (unless there was a sophisticated integrated diagnostic AI, which is not indicated here). Its "performance" would be its direct therapeutic effect, not an algorithmic output that requires standalone evaluation.
-
Type of Ground Truth Used (Hypothetical):
- (e.g., Expert Clinical Assessment: Standardized clinical photography, physical examination by dermatologists using validated scales (e.g., Fitzpatrick Wrinkle Scale for wrinkles, inflammatory lesion counts for acne, Investigator Global Assessment (IGA) for overall severity), and patient-reported outcomes via validated questionnaires.)
-
Sample Size for the Training Set (Hypothetical):
- Not Applicable: Since no AI/ML algorithm requiring a training set is mentioned or implied for efficacy assessment in the 510(k) summary, this concept does not apply here. The device's "training" for efficacy would be its clinical development and demonstration through clinical trials.
-
How Ground Truth for the Training Set Was Established (Hypothetical):
- Not Applicable: As above, no training set for an algorithm is relevant to the information provided. If it were a predictive AI device, the ground truth would typically be established by expert consensus (e.g., multiple dermatologists labeling images) or by linking imaging data to ground truth data (e.g., biopsy results for skin conditions).
In summary, the provided 510(k) clearance documentation for the GLAM LED Facial Mask focuses solely on the device's substantial equivalence in design, technology, and safety compliance according to international standards for electrical safety, EMC, biocompatibility, and photobiological safety. It explicitly states that no clinical or animal studies were included in the submission to demonstrate efficacy for its intended uses (wrinkle reduction and acne treatment). The FDA cleared this device based on its similarity to previously cleared predicate devices and its adherence to safety standards, implying that its efficacy is presumed to be similar to those predicates without requiring new clinical proof for this specific submission.
FDA 510(k) Clearance Letter - GLAM LED Facial Mask
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.08.00
Silver Spring, MD 20993
www.fda.gov
August 29, 2025
Touchbeauty Beauty & Health (shenzhen) Co., Ltd
℅ Owen He
Consultant
Microkn Medical Technology Service (Shanghai) Co.,Ltd.
Room 901, Huafa Center, 889 Pinglu Road, Jing 'an District,
Shanghai, Shanghai 200040
China
Re: K251727
Trade/Device Name: GLAM LED Facial Mask (TB-2386F)
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
Dated: June 5, 2025
Received: June 5, 2025
Dear Owen He:
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.
Page 2
K251727 - Owen He Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
Page 3
K251727 - Owen He Page 3
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).
Sincerely,
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.08.29 12:23:12 -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 (6/20) 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: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K251727
Device Name
GLAM LED Facial Mask(TB-2386F)
Indications for Use (Describe)
The Red Light is intended to treat full face wrinkles.
The Blue Light is intended to treat mild to moderate inflammatory acne.
The Yellow Light is intended to treat 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
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."
Page 5
510(k) Summary
510(k) #: K251727
Prepared on: 2025-08-28
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD. |
|---|---|
| Applicant Address | 29/F, Block B, Tiley Central Plaza, No.195 Haide 3rd Road, Nanshan District, Shenzhen Guangdong China |
| Applicant Contact Telephone | 13537806505 |
| Applicant Contact | Mr. Shidong Qin |
| Applicant Contact Email | qinshidong@touchbeauty.com |
| Correspondent Name | Microkn Medical Technology Service (Shanghai) Co.,Ltd. |
| Correspondent Address | Room 901, Huafa Center, 889 Pinglu Road, Jing 'an District, Shanghai Shanghai Shanghai 200040 China |
| Correspondent Contact Telephone | 13641938412 |
| Correspondent Contact | Mr. Owen He |
| Correspondent Contact Email | fda@microkn.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | GLAM LED Facial Mask (TB-2386F) |
|---|---|
| Common Name | Laser surgical instrument for use in general and plastic surgery and in dermatology |
| Classification Name | Powered Laser Surgical Instrument |
| Regulation Number | 878.4810 |
| Product Code(s) | OHS&OLP |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K230293 | TheraFace Mask | OHS&OLP |
| K242700 | Radiant Renewal Skincare Lid | OHS&OLP |
Device Description Summary
21 CFR 807.92(a)(4)
The GLAM LED light therapy mask is a home use wearable light emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full face wrinkles and mild to moderate acne of the face. The outer shell of the mask is manufactured from Polyethylene terephthalate (PET). The inner shell is a clear Polycarbonate (PC). The Light emitting diodes are mounted behind the clear Polycarbonate. The LEDs generate the light. The ear hooks are made of Acrylonitrile butadiene styrene (ABS) and the silicone goggle protect the eyes from LED lights. Unfold the ear hooks and place the mask on your face, the mask will automatically activate the light therapy mode.
Page 6
The LEDs produce blue, red and yellow light in the visible spectrum (Blue:415nm +/- 10nm, Yellow: 590nm +/-10nm, Red: 625nm +/-10nm.). The device works by emitting the specified wavelengths to treat full face of wrinkles or to treat mild to moderate inflammatory acne.
Press the touch switch on the right ear hook twice to select the light therapy mode you want to use. Each mode operates in a 15-minute cycle. After 15 minutes, the device automatically deactivates the light mode and enters the standby mode.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Red Light is intended to treat full face wrinkles.
The Blue Light is intended to treat mild to moderate inflammatory acne.
The Yellow Light is intended to treat wrinkles.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The subject and predicate devices share the same indications for use.
Technological Comparison
21 CFR 807.92(a)(6)
The Subject Device (GLAM LED Facial Mask, Model: TB-2386F) and the legally marketed Predicate Device (TheraFace Mask & Radiant Renewal Skincare Lid) are all powered laser surgical instrument sharing Product Codes OHS and OLP falling under regulatory classification 21 CFR 878.4810. These devices all light emitting diode phototherapy device whose purpose is to produce band of light for the treatment of full-face wrinkles and mild to moderate acne of the face.
The power supply of Subject device and Predicate devices are very similar, but not identical, the IEC-60601-1 test demonstrated the safety of the power adapter. The slight difference will not raise safety and effective issue.
Key differences between Subject Device and Predicate Device lie in "Power Density" and "Treatment Time". The "Standard Dose in Joule" can be calculated as the product of "Power Density" x "Treatment Time". This would may be achieved using either a high power density over a short treatment time or a low power density over a longer treatment time. Although the power density and treatment time of the Subject device and the Predicate devices differ, the resulting standard dose in Joules is comparable and falls within an acceptable deviation range. The device has successfully passed testing in accordance with IEC 60601-2-57, confirming that its performance and safety profile remain unaffected. Thus, these variations do not pose any concerns regarding safety or effectiveness.
Non-clinical testing confirms biocompatibility compliance with ISO 10993-5/-10/-23(no cytotoxicity, sensitization or irritation), electrical safety (IEC 60601-1-2), EMC (60601-1-2), laser use (IEC 60601-2-57 & IEC 62471).
In conclusion, the Subject Device demonstrates substantial equivalence to Predicate in technical principles, clinical functionality, and safety thresholds, satisfying FDA 510(k) substantial equivalence criteria for market authorization.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following testing items and standards:
Electromagnetic Compatibility (EMC) and Electrical Safety
IEC 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, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC TR 60601-4-2:2016, Medical electrical equipment- Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
IEC 60601-1-11:2020 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
IEC 60601-2-57 Edition 1.0 2011-01 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
IEC 60601-2-83: 2023 Medical electrical equipment –Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
Biocompatibility test
For the components in contact with the human body, in vitro cytotoxicity test, skin irritation test, skin sensitization test and systemic toxicity test were conducted according to:
ISO 10993-5:2009, Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
ISO 10993-10:2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for irritation
Page 7
Photobiological Safety
The photobiological safety was tested according to IEC 62471:2006 - Photobiological safety of lamps and lamp systems
Software verification and validation testing
IEC 62304: 2006 (ed. 1.0) Medical Device Software - Software Life Cycle Processes
Clinical Testing
No animal or clinical study is included in this submission
The subject device is substantial equivalence as the predicate devices K230293 and K242700
§ 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.