Omnilux CLEAR
Over-the-counter Powered Light Based Laser For Acne
GlobalMed Technologies
The following data is part of a premarket notification filed by Globalmed Technologies with the FDA for Omnilux Clear.
Pre-market Notification Details
| Device ID | K210948 |
| 510k Number | K210948 |
| Device Name: | Omnilux CLEAR |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | GlobalMed Technologies 163 Camino Dorado, Ste B Napa, CA 94558 |
| Contact | Lisa Thorson |
| Correspondent | Lisa Thorson GlobalMed Technologies 163 Camino Dorado, Ste B Napa, CA 94558 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-03-30 |
| Decision Date | 2021-06-24 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060534510234 | K210948 | 000 |
Trademark Results [Omnilux CLEAR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMNILUX CLEAR 98469063 not registered Live/Pending |
The Lotus Global Group, Inc. 2024-03-26 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.