The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Trusculpt.
Device ID | K122389 |
510k Number | K122389 |
Device Name: | TRUSCULPT |
Classification | Massager, Vacuum, Radio Frequency Induced Heat |
Applicant | CUTERA, INC. 3240 BAYSHORE BLVD Brisbane, CA 94005 |
Contact | Connie Hoy |
Correspondent | Connie Hoy CUTERA, INC. 3240 BAYSHORE BLVD Brisbane, CA 94005 |
Product Code | PBX |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-08-07 |
Decision Date | 2012-11-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TRUSCULPT 77662751 4125795 Live/Registered |
Cutera, Inc. 2009-02-03 |
TRUSCULPT 75207760 2268025 Dead/Cancelled |
Franklin Mint Company 1996-12-04 |