The following data is part of a premarket notification filed by Trophy Skin, Inc. with the FDA for Rejuvalite Md.
Device ID | K133896 |
510k Number | K133896 |
Device Name: | REJUVALITE MD |
Classification | Light Based Over The Counter Wrinkle Reduction |
Applicant | TROPHY SKIN, INC. 2424 DEMPSTER DRIVE Coralville, IA 52241 |
Contact | Susan Anthoney-dewet |
Correspondent | Susan Anthoney-dewet TROPHY SKIN, INC. 2424 DEMPSTER DRIVE Coralville, IA 52241 |
Product Code | OHS |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-12-20 |
Decision Date | 2014-11-13 |
Summary: | summary |