Identifiers
- 510(k) Number
- K172662 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 Perioral is a light-based, over-the-counter wrinkle reduction device. It utilizes red and infrared diodes to provide narrow bands of light energy to treat wrinkles.
This device is applied directly to the skin to ensure consistent administration of light during each treatment. The system includes the LED module, a USB charging cord, and a storage bag. It is authorized under FDA 510(k) K172662.
Frequently asked questions
What is the primary purpose of the reVive Perioral?
The reVive Perioral is designed as an over-the-counter device for wrinkle reduction. It functions by delivering narrow bands of light energy to the skin using red and infrared diodes.
How is the device powered and what is included in the package?
The system is supplied with the LED module, a USB charging cord for power, and a storage bag to keep the components together when not in use.
How should the device be applied during treatment?
The device is applied directly to the skin surface. This direct contact method is used to ensure the consistent administration of light energy throughout each treatment session.
What is the regulatory status of this device?
The reVive Perioral is authorized under FDA 510(k) number K172662, which indicates it has been reviewed and cleared for market as a light-based wrinkle reduction device.
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 Perioral (K172662) — FDA 510 (k) | Innolitics, Shop All reVive Light Therapy™ and dpl® Products - LED Technologies, Inc, PDF LED Technologies, Inc. Ms. Jelena Barbaric Compliance Manager, reVive Perioral (K172662) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172662 | Class II | Active |
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Manufacturer
- Manufacturer
- Led Technologies, Inc.
Sources (1)
- FDA 510(k) K172662 24 fields · synced Sep 22, 2026