TruSculpt
Massager, Vacuum, Radio Frequency Induced Heat
Cutera, Inc.
The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Trusculpt.
Pre-market Notification Details
| Device ID | K172004 |
| 510k Number | K172004 |
| Device Name: | TruSculpt |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | Cutera, Inc. 3240 Bayshore Blvd. Brisbane, CA 94005 |
| Contact | Bradley Renton |
| Correspondent | Bradley Renton 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 | 2017-07-03 |
| Decision Date | 2017-08-02 |
| Summary: | summary |
Trademark Results [TruSculpt]
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 |
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