OMNILUX BLUE
Powered Laser Surgical Instrument
PHOTO THERAPEUTICS LIMITED
The following data is part of a premarket notification filed by Photo Therapeutics Limited with the FDA for Omnilux Blue.
Pre-market Notification Details
| Device ID | K030883 |
| 510k Number | K030883 |
| Device Name: | OMNILUX BLUE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PHOTO THERAPEUTICS LIMITED 5 TIMBER LN. North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell PHOTO THERAPEUTICS LIMITED 5 TIMBER LN. North Reading, MA 01864 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-20 |
| Decision Date | 2003-06-18 |
| Summary: | summary |
Trademark Results [OMNILUX BLUE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMNILUX BLUE 78190321 3237861 Live/Registered |
THE LOTUS GLOBAL GROUP, INC. 2002-12-02 |
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