The following data is part of a premarket notification filed by Cutera Inc. with the FDA for Trusculpt Id.
| Device ID | K223110 |
| 510k Number | K223110 |
| Device Name: | TruSculpt ID |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Cutera Inc. 3240 Bayshore Blvd. Brisbane, CA 94005 |
| Contact | Julia Brown |
| Correspondent | Julia Brown Cutera Inc. 3240 Bayshore Blvd. Brisbane, CA 94005 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-10-03 |
| Decision Date | 2022-11-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TRUSCULPT ID 97109619 not registered Live/Pending |
Cutera, Inc. 2021-11-04 |