The following data is part of a premarket notification filed by Photo Therapeutics Limited with the FDA for Omnilux Blue.
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OMNILUX BLUE 78190321 3237861 Live/Registered |
THE LOTUS GLOBAL GROUP, INC. 2002-12-02 |