The following data is part of a premarket notification filed by Ir Technology Llc with the FDA for Invisa-red Elite.
| Device ID | K192275 |
| 510k Number | K192275 |
| Device Name: | Invisa-RED ELITE |
| Classification | Fat Reducing Low Level Laser |
| Applicant | IR Technology LLC 2707 Hampton TRL Woodstock, GA 30189 |
| Contact | Thomas A. Namynanik |
| Correspondent | Thomas A. Namynanik Vidantis Technologies, Inc 300 Lismore Terrace Woodstock, GA 30189 |
| Product Code | OLI |
| CFR Regulation Number | 878.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-22 |
| Decision Date | 2020-08-19 |