OMNILUX CLEAR-U
Over-the-counter Powered Light Based Laser For Acne
PHOTO THERAPEUTICS, INC.
The following data is part of a premarket notification filed by Photo Therapeutics, Inc. with the FDA for Omnilux Clear-u.
Pre-market Notification Details
| Device ID | K081307 |
| 510k Number | K081307 |
| Device Name: | OMNILUX CLEAR-U |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | PHOTO THERAPEUTICS, INC. 2720 LOKER AVENUE WEST Carlsbad, CA 92010 |
| Contact | Sue Darcy |
| Correspondent | Sue Darcy PHOTO THERAPEUTICS, INC. 2720 LOKER AVENUE WEST Carlsbad, CA 92010 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-08 |
| Decision Date | 2009-01-16 |
| Summary: | summary |
Trademark Results [OMNILUX CLEAR-U]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMNILUX CLEAR-U 77328108 3942533 Live/Registered |
THE LOTUS GLOBAL GROUP, INC. 2007-11-13 |
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