FDA 510(k) Premarket Clearance

The U.S. Food and Drug Administration has cleared the LIGHT WELLNESS LED Light Therapy Mask under 510(k) Premarket Notification, confirming it as Substantially Equivalent to legally marketed predicate devices for over-the-counter wrinkle reduction.

Regulatory Details

Field	Value
510(k) Number	K251667
Applicant	Shenzhen DVTsmart Technology Co., Ltd.
Device Name	LED Light Therapy Mask
Classification	Class II Medical Device
Regulation Number	21 CFR 878.4810
Product Code	OAP
Intended Use	Over-the-counter (OTC) use for the treatment of periorbital wrinkles and rhytides
Decision Date	August 7, 2025
Registration Number	3031595583
Device Listing	DVTsmart LED Light Therapy Mask M09

What 510(k) Clearance Means

The 510(k) Premarket Notification is the most common FDA pathway for medical devices. It requires the manufacturer to demonstrate that their device is "Substantially Equivalent" to a legally marketed predicate device — meaning it has the same intended use and technological characteristics, or differences do not raise new questions of safety and effectiveness.

For our LED Light Therapy Mask, the FDA reviewed our device's wavelengths, power output, safety testing, biocompatibility data, and clinical evidence before determining it could be legally marketed for OTC wrinkle reduction in the United States.

Regulation 21 CFR 878.4810

This regulation covers "carbon dioxide laser surgical system" devices intended for use in general and plastic surgery and dermatology. Our device was cleared under the OTC subset of this regulation, which covers non-ablative light-based devices for cosmetic wrinkle reduction that do not use ablative lasers.

The key safety requirements under this regulation include:

• Eye safety: The device must not emit hazardous optical radiation levels
• Thermal safety: Surface temperature must not cause tissue damage
• Electrical safety: Device must meet IEC 60601-1 electrical safety standards
• Biocompatibility: All patient-contacting materials must pass ISO 10993 testing
• Labeling: Must include clear instructions, contraindications, and warnings

Predicate Device Comparison

The FDA's Substantial Equivalence determination was based on comparison with legally marketed LED light therapy devices that share the same intended use (OTC wrinkle reduction) and similar technological characteristics (LED-based, non-ablative, red and near-infrared wavelengths). Our device was found to be as safe and effective as these predicate devices.

What This Means for You

When you see "FDA Cleared" on a light therapy device, it means the FDA has reviewed the safety and efficacy data and determined the device can be legally marketed for its intended use. This is different from "FDA Registered" — which only means a facility has registered with the FDA, not that any specific device has been reviewed.

Our 510(k) clearance (K251667) means the LIGHT WELLNESS LED Mask has been independently reviewed by the FDA and found safe and effective for over-the-counter wrinkle reduction. You can verify this clearance on the FDA's official 510(k) database by searching for K251667.