(64 days)
No
The device description indicates it is a light therapy system controlled by a physical controller for power, mode, and time adjustments, with no mention of AI, machine learning, or complex adaptive functionalities.
Yes
The device is intended for the treatment of inflammatory acne and facial wrinkles, which are medical conditions, and uses light therapy as a treatment modality.
No
The device description and intended use clearly state that it is for treatment purposes (treating acne and wrinkles) using light therapy, not for diagnosing any medical condition.
No
The device is a hardware-based medical device. The description clearly states it is a "wearable light based device" that generates light via "LED with four different spectrum wavelengths." It is also "powered by external power supply" and "controlled by the controller." The performance studies include "Electrical Safety and EMC" and "Biocompatibility Testing," which are typical for hardware devices. While it does mention "Software Verification and Validation," this is for controlling the hardware, not an indication that the device itself is purely software.
No
The device uses light therapy for the treatment of acne and wrinkles, which is a physical intervention, not an in vitro diagnostic process that examines specimens from the human body.
N/A
Intended Use / Indications for Use
- Blue light: Treatment of mild to moderate inflammatory acne.
- Red+IR light: Treatment of facial wrinkles.
- Amber light: Treatment of facial wrinkles.
- Mixed light: Treatment of mild to moderate inflammatory acne.
Product codes
OHS, OLP
Device Description
The Light Therapy System is an Over-the-Counter (OTC), home-use, wearable light based device, and intended for the use in treating full-face wrinkles and mild to moderate inflammatory acne. Light radiates from the inner surface of the device onto the face. This light is generated by LED with four different spectrum wavelengths: blue (460nm), amber (605nm), red (630nm) and infrared (850nm), and the device has four light treatment, that is, blue light and mixed light mode to treat acne, while amber light mode and red+ IR mode to treat facial wrinkles.
The device is powered by external power supply by connecting with the power adapter and controlled by the controller that should be connected to the main unit. The device's power-on/off, mode switch and treatment time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home-use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Biocompatibility Testing: Evaluation for body-contacting components in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23. All tests passed.
- Electrical Safety and EMC: Testing performed to and passed IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, and IEC 62471.
- Software Verification and Validation: Software documentation consistent with Basic Documentation level of concern was submitted. System validation testing demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Key Results: Based on the analysis and non-clinical tests, the subject device is concluded to be as safe, as effective, and performs as well as the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K230351, K171323, K221151, K200983, K223544, K241718
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
FDA 510(k) Clearance Letter - Light Therapy System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov
June 6, 2025
Guangzhou Ahead Intelligent Technology Co., Ltd.
℅ Riley Chan
Registration engineer
Feiying Drug & Medical Consulting Technical Service Group
Rm 2401 Zhenge International Business Center, No. 3101-90
Qianhai Road
Shenzhen, Guangdong 518052
China
Re: K251042
Trade/Device Name: Light Therapy System (M500, L6)
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: March 31, 2025
Received: April 3, 2025
Dear Riley Chan:
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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K251042 - Riley Chan 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-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
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K251042 - Riley Chan Page 3
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.06.06 13:34:52 -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
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K251042
Please provide the device trade name(s).
Light Therapy System (M500, L6)
Please provide your Indications for Use below.
- Blue light: Treatment of mild to moderate inflammatory acne.
- Red+IR light: Treatment of facial wrinkles.
- Amber light: Treatment of facial wrinkles.
- Mixed light: Treatment of mild to moderate inflammatory acne.
Please select the types of uses (select one or both, as applicable).
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)
Light Therapy System Page 9 of 41
Page 5
K251042 - 510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
Guangzhou Ahead Intelligent Technology Co., Ltd.
Room 505, Building 2, No.10, Industrial 1st Road, Zhicun, Dashi Street, Panyu District, Guangzhou, Guangdong, China
Post code: 511430
Leo Zheng
General manager
Tel: +86 18664649916
Email: 187308650@qq.com
Prepared date: 2025-6-4
II. Device
Name of Device: Light Therapy System
Model(s): M500, L6
Common or Usual Name: Light Based Over The Counter Wrinkle Reduction
Over-The-Counter Powered Light Based Laser For Acne
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II
Product Code: OHS, OLP
Regulation Number: 21 CFR 878.4810
III. Predicate Device & Reference Device
Predicate device
| Manufacturer | Trade Name | 510(k) Number | Cleared Date |
|---|---|---|---|
| Shenzhen SUNGPO HI-TECH Electronic Co.,Ltd | LED Facial Mask/ MZ-01, NEWKEY01, SP-FM-01 | K230351 | May 5, 2023 |
| Hunan Guangye Biotechnology Co., Ltd. | Beauty LED Mask/ Model:KFB265 | K221151 | July 19, 2022 |
| Guangdong Newdermo Biotech Co.,Ltd | LED light therapy mask (FM-01, FM-02, FM-03) | K223544 | Feb. 23, 2023 |
| Biophotas Inc | Biophotas Celluma3 | K171323 | Sep. 1, 2017 |
| Ningbo Hesi Electric Co., Ltd | Flexible LED light therapy (Model: HK209) | K200983 | July 14, 2021 |
| Shenzhen Aozemei Technology Co., LTD | Micro-current Facial Beauty Device | K241718 | Oct. 28, 2024 |
Reference device
Page 6
| Manufacturer | Trade Name | 510(k) Number | Cleared Date |
|---|---|---|---|
| Marci Beauty Inc | Infrared Red Blue LED Light Heat Beauty Machine | K210545 | May 20, 2022 |
| Shenzhen Borria Technology Co., Ltd | LED Therapy Mask (MN1, M226) | K242385 | April 7, 2025 |
| Galactic Beauty, LLC | MMSphere | K190443 | June 24, 2019 |
IV. Device Description
The Light Therapy System is an Over-the-Counter (OTC), home-use, wearable light based device, and intended for the use in treating full-face wrinkles and mild to moderate inflammatory acne. Light radiates from the inner surface of the device onto the face. This light is generated by LED with four different spectrum wavelengths: blue (460nm), amber (605nm), red (630nm) and infrared (850nm), and the device has four light treatment, that is, blue light and mixed light mode to treat acne, while amber light mode and red+ IR mode to treat facial wrinkles.
The device is powered by external power supply by connecting with the power adapter and controlled by the controller that should be connected to the main unit. The device's power-on/off, mode switch and treatment time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over.
V. Indications for Use
- Blue light: Treatment of mild to moderate inflammatory acne.
- Red+IR light: Treatment of facial wrinkles.
- Amber light: Treatment of facial wrinkles.
- Mixed light: Treatment of mild to moderate inflammatory acne.
VI. Comparison of Technological Characteristics With the Predicate Device
The Light Therapy System has the same intended use as the predicate devices. The technological characteristics such as wavelength, intensity, are similar to the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices for its intended use. Therefore, the Light Therapy System may be found substantially equivalent to its predicate devices.
Table1: Substantial Equivalence Comparison for M500
Page 7
| Items | Subject device | Primary Predicate device | Predicate device 1 | Predicate device 2 | Predicate device 3 | Reference device 1 | Reference device 2 | Difference discussion |
|---|---|---|---|---|---|---|---|---|
| K number | K251042 | K230351 | K221151 | K223544 | K241718 | K210545 | K190443 | / |
| Device name | Light Therapy System (Model: M500) | LED Facial Mask/ MZ-01, NEWKEY01, SP-FM-01 | Beauty LED Mask/ Model: KFB265 | LED light therapy mask (FM-01, FM-02, FM-03) | Micro-current Facial Beauty Device, Model: AM-810B, AM-810W, AM-812B, AM-812W | Infrared Red Blue LED Light Heat Beauty Machine | MMSphere™ | / |
| Product Code | OHS, OLP | OHS, OLP | OHS, OLP | OHS, OLP, ILY | OHS, OLP | OHS, OLP | OHS, OLP | Same |
| Intended use/ Indications for Use | Blue light: Treatment of mild to moderate inflammatory acne. Red+IR light: Treatment of facial wrinkles. Amber light: Treatment of facial wrinkles. Mixed light: 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 device is intended to use LED light for the treatment of wrinkles and mild to moderate acne. | 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. | Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. | The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the face and the blue light is intended for the treatment of the mild to moderate inflammatory acne. This device is indicated for adults only. | MMSphere™ Light Therapy Device emits energy in the red, blue and amber regions of the spectrum, specifically indicated to treat wrinkles and/or mild to moderate acne. The MMSphere™ is designed to be used for 20 minute treatments three to seven times per week. | Same |
| Prescription /OTC | OTC | OTC | OTC | OTC | OTC | OTC | OTC | Same |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Same |
| Power supply | External adapter 100-240 V ~ 50/60 Hz | External adapter Input:AC100-240V 50-60Hz 0.2A Output: DC 12V 0.5A | Input: 100-240 V~, 50/60 Hz Output: 5V 1A | Input: 100-240V~, 50/60Hz, 0,25A Output: DC 5 V, 500 mA | Adapter input: 5V 0.5A Internal battery: 3.7V/600mAh | 900mAh, Rechargeable Li-Ion batteries | Unknown | Same |
Page 8
| Items | Subject device | Primary Predicate device | Predicate device 1 | Predicate device 2 | Predicate device 3 | Reference device 1 | Reference device 2 | Difference discussion |
|---|---|---|---|---|---|---|---|---|
| Shape design | M500: Mask | Mask | Mask | Mask | Hand-held Type | Hand-held Type | Handheld and stationary | Similar |
| Intended location of use | Face | Face | Face | Face and body | Face | Entire Face | Face | Same |
| Energy type | Light emitting diodes (LEDs) | Light emitting diodes (LEDs) | Light emitting diodes (LEDs) | LED | LED | LED | LED | Same |
| Wavelength | Blue: 460nm±5nm Red: 630nm±5nm Amber: 605nm±5nm Near-infrared: 850nm±5nm | Blue: 465nm±5nm Red: 625nm±5nm Amber: 605nm±5nm | Red (637nm±5nm)and IR (854nm±5nm); Blue (465±5nm) | Red: 620nm Blue: 460nm Infrared: 850nm Mixed: 620nm and 850nm and 460nm | Blue: 415±10nm Amber: 605±10nm Red: 630±10nm | Blue: 465nm Red: 620-630nm IR: 845-855nm | 605nm 625nm 465nm | Similar |
| Intensity (mW/cm²) | M500: Blue: 40mW/cm² Amber: 10mW/cm² Red+IR: 20mW/cm² Mixed mode: 12mW/cm² | Blue: 15 | Red+IR: 25.5mW/cm² Blue: 1.36mW/cm² | Red light: 2.0 | Red: 2.5mW/cm2 Amber: 15mW/cm2 Blue: 1.4mW/cm2 | Blue light: 5.4mW/cm2 Red+IR light: 7.2mW/cm2 | Red 2.45mW/cm2 Blue 1.33mW/cm2 Amber: unpublished | Similar |
| Treatment time | 10 minutes each time, 3~5 times a week | 10 minutes/day, 3 times per week | 10min each 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. | 3-5 minutes at a time /2-3 times a week. | 3 times a week for 30 min. 4weeks | 20mins/day, 120days | Similar |
| Main materials | Nylon+spandex, PVC leather, ABS plastic | ABS and PC plastic | Unknown | Unknown | ABS, PC | ABS Plastic and Aluminum Head | Unknown | Different, but solved by biocompatibility test |
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Table 2: Substantial Equivalence Comparison for L6
| Items | Subject device | Primary Predicate device | Predicate device 1 | Predicate device 2 | Predicate device 3 | Predicate device 4 | Reference device 1 | Reference device 2 | Difference discussion |
|---|---|---|---|---|---|---|---|---|---|
| K number | K251042 | K171323 | K230351 | K200983 | K223544 | K241718 | K242385 | K190443 | / |
| Device name | Light Therapy System (Model: L6) | Biophotas Celluma3 | LED Facial Mask/ MZ-01, NEWKEY01, SP-FM-01 | Flexible LED light therapy (Model: HK209) | LED light therapy mask (FM-01, FM-02, FM-03) | Micro-current Facial Beauty Device, Model: AM-810B, AM-810W, AM-812B, AM-812W | LED Therapy Mask (MN1, M226) | MMSphere™ | / |
| Product Code | OHS, OLP | OHS | OHS, OLP | OHS, OLP, ILY | OHS, OLP, ILY | OHS, OLP | OHS, OLP, ILY | OHS, OLP | Same |
| Intended use/ Indications for Use | Blue light: Treatment of mild to moderate inflammatory acne. Red+IR light: Treatment of facial wrinkles. Amber light: Treatment of facial wrinkles. Mixed light: Treatment of mild to moderate inflammatory acne. | The BioPhotas Celluma3 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full face wrinkles. | 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 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 temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of | 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. | Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. | Red light: Treatment of full-face wrinkles. Blue light (only suitable model M226 and MN1 LED Facial Mask): 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. | MMSphere™ Light Therapy Device emits energy in the red, blue and amber regions of the spectrum, specifically indicated to treat wrinkles and/or mild to moderate acne. The MMSphere™ is designed to be used for 20 minute treatments three to seven times per week. | Same |
Page 10
| Items | Subject device | Primary Predicate device | Predicate device 1 | Predicate device 2 | Predicate device 3 | Predicate device 4 | Reference device 1 | Reference device 2 | Difference discussion |
|---|---|---|---|---|---|---|---|---|---|
| Prescription /OTC | OTC | OTC | OTC | OTC | OTC | OTC | OTC | OTC | Same |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Same |
| Power supply | External adapter 100-240 V ~ 50/60 Hz | An AC adaptor for 110-120V | External adapter Input:AC100-240V 50-60Hz 0.2A Output: DC 12V 0.5A | Input: 100–240Vac, 2.0A, 50/60Hz | Input: 100-240V~, 50/60Hz, 0,25A Output: DC 5V, 500mA | Adapter input: 5V 0.5A Internal battery: 3.7V/600mAh | Input: DC 5V, 1A Built-in rechargeable lithium battery: DC 3.7V 2500mAh | Unknown | Same |
| Shape design | L6: Panel | Panel | Mask | Panel | Mask | Hand-held Type | Mask | Handheld and stationary | Similar |
| Intended location of use | Face | Whole face | Face | Entire Face and body | Face and body | Face | Face and neck | Face | Same |
| Energy type | Light emitting diodes (LEDs) | Light emitting diodes (LEDs) | Light emitting diodes (LEDs) | LED | LED | LED | LEDs | LED | Same |
| Wavelength | Blue: 460nm±5nm Red: 630nm±5nm Amber: 605nm±5nm Near-infrared: 850nm±5nm | Red:640nm+/-25nm NIR:880nm+/-50nm | Blue: 465nm±5nm Red: 625nm±5nm Amber: 605nm±5nm | 465nm, 640nm, 880nm | Red: 620nm Blue: 460nm Infrared: 850nm Mixed: 620nm and 850nm and 460nm | Blue: 415±10nm Amber: 605±10nm Red: 630±10nm | Red: 630nm±5nm Blue: 470nm±5nm Near-Infrared: 850nm±5nm Mixed light: 630nm and 850nm | 605nm 625nm 465nm | Similar |
| Intensity (mW/cm²) | At 1cm: Blue: 1.6 | 6.5mW/cm² | Blue: 15 | 6.5mW/cm² | Red light: 2.0 | Red: 2.5mW/cm² Amber: 15mW/cm² Blue: 1.4mW/cm² | Red: 0.89 | Red 2.45mW/cm² Blue 1.33mW/cm² Amber: unpublished | Similar |
Page 11
| Items | Subject device | Primary Predicate device | Predicate device 1 | Predicate device 2 | Predicate device 3 | Predicate device 4 | Reference device 1 | Reference device 2 | Difference discussion |
|---|---|---|---|---|---|---|---|---|---|
| The distance between the LEDs to treatment surface | 1~5cm | As closed to the skin | As closed to the skin | 10cm | As closed to the skin | As closed to the skin | As closed to the skin | Unknown | Similar Note 4 |
| Treatment time | 10 minutes each time, 3~5 times a week | 3 treatments per week (1800 seconds) 4 weeks | 10 minutes/day, 3 times per week | 3 times a week for 30 min. 4 weeks | 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. | 3-5 minutes at a time /2-3 times a week. | 10 minutes each time | 20mins/day, 120 days | Similar |
| Main materials | Nylon+spandex, PVC leather, ABS plastic | Unknown | ABS and PC plastic | Unknown | Unknown | ABS, PC | Unknown | Unknown | Different, but solved by biocompatibility test |
Page 12
VII. Non-Clinical Testing
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the Light Therapy System was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process', Document Issued on September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including:
- ISO 10993-5: 2009, Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10: 2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23: 2021, Biological evaluation of medical devices - Part 23: Tests for irritation
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, as per the following standards:
- IEC 60601-1:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2020, Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility
- IEC 60601-1-11:2020, Medical Electrical Equipment –Part 1: General Requirements for Basic Safety and Essential Performance –Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- IEC 60601-2-83: 2022, Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
- IEC 62471: 2006, Photobiological safety of lamps and lamp systems
3) Software Verification and Validation
Software documentation consistent with Basic Documentation level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
VIII. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device Light Therapy System is as safe, as effective, and performs as well as the legally marketed predicate devices.