ReVive Light Therapy LED Ultrasonic Wrinkle System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180445 FDA 510(k)
- FDA Product Code
- OHS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ReVive Light Therapy LED Ultrasonic Wrinkle System is a Class II medical device that uses LED light technology for over-the-counter wrinkle reduction. It combines LED light therapy with ultrasonic technology to address skin concerns related to aging and wrinkles.
This device is manufactured by LED Technologies, Inc. and is FDA 510(k) cleared with product code OHS. It is intended for use in general and plastic surgery settings. The device is supplied as a complete system for at-home use and should be stored according to the manufacturer's instructions.
Frequently asked questions
What is the reVive Light Therapy LED Ultrasonic Wrinkle System used for?
The reVive Light Therapy LED Ultrasonic Wrinkle System is a Class II medical device designed for over-the-counter wrinkle reduction. It combines LED light therapy with ultrasonic technology to address skin concerns related to aging and wrinkles, intended for use in general and plastic surgery settings.
How is the reVive Light Therapy LED Ultrasonic Wrinkle System supplied?
The device is supplied as a complete system for at-home use. It should be stored according to the manufacturer's instructions to maintain its functionality and safety. The system includes all necessary components for LED light therapy and ultrasonic treatment.
What is the regulatory status of the reVive Light Therapy LED Ultrasonic Wrinkle System?
The reVive Light Therapy LED Ultrasonic Wrinkle System is FDA 510(k) cleared with product code OHS. It received clearance on May 15, 2018, and is classified as a Class II medical device for light-based over-the-counter wrinkle reduction.
Is the reVive Light Therapy LED Ultrasonic Wrinkle System reusable or single-use?
The device is designed for repeated use at home. It is not specified as single-use, indicating it can be used multiple times following the manufacturer's instructions for proper maintenance and care to ensure continued effectiveness and safety.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: reVive Light Therapy - Official Website, Medical Grade LED Light Skin Therapy | LED Technologies, Inc, LED Technologies, Inc - reVive Light Therapy™, Shop All reVive Light Therapy™ and dpl® Products - LED Technologies, Inc, Red Light Therapy Devices for Anti-Aging & Wrinkle Reduction
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180445 | Class II | Active |
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Manufacturer
- Manufacturer
- Led Technologies, Inc.
Sources (1)
- FDA 510(k) K180445 24 fields · synced Sep 22, 2026