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 |