The following data is part of a premarket notification filed by Led Technologies, Inc. with the FDA for Revive Light Therapy Led Cleansing System.
| Device ID | K221430 |
| 510k Number | K221430 |
| Device Name: | ReVive Light Therapy LED Cleansing System |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | LED Technologies, Inc. 12821 Starkey Rd., Suite 4900 Largo, FL 33773 |
| Contact | Jelena Barbaric |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-17 |
| Decision Date | 2022-07-27 |