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 | K180447 |
| 510k Number | K180447 |
| Device Name: | ReVive Light Therapy LED Cleansing System |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | LED Technologies, Inc. 6000 Greenwood Plaza Blvd., Suite 110 Greenwood Village, CO 80111 |
| Contact | Lloyd Nelson |
| Correspondent | Jelena Barbaric LED Technologies, Inc. 6000 Greenwood Plaza Blvd., Suite 110 Greenwood Village, CO 80111 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-20 |
| Decision Date | 2018-06-04 |
| Summary: | summary |