The following data is part of a premarket notification filed by Photo Therapeutics, Inc. with the FDA for Omnilux New-u.
| Device ID | K072459 |
| 510k Number | K072459 |
| Device Name: | OMNILUX NEW-U |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| 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 | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-31 |
| Decision Date | 2008-03-03 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OMNILUX NEW-U 77328109 3995523 Live/Registered |
THE LOTUS GLOBAL GROUP, INC. 2007-11-13 |