The following data is part of a premarket notification filed by Led Technologies, Inc. with the FDA for Revive Light Therapy Essentials.
| Device ID | K210965 |
| 510k Number | K210965 |
| Device Name: | ReVive Light Therapy Essentials |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | LED Technologies, Inc. 12821 Starkey Rd., Suite 4900 Largo, FL 33773 |
| Contact | Lloyd Nelson |
| Correspondent | Jelena Barbaric LED Technologies, Inc. 12821 Starkey Rd., Suite 4900 Largo, FL 33773 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-31 |
| Decision Date | 2021-12-15 |