The following data is part of a premarket notification filed by Photo Therapeutics, Inc. with the FDA for Omnilux Clear-u.
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OMNILUX CLEAR-U 77328108 3942533 Live/Registered |
THE LOTUS GLOBAL GROUP, INC. 2007-11-13 |