The following data is part of a premarket notification filed by Cutera Inc. with the FDA for Trusculpt Id.
Device ID | K221407 |
510k Number | K221407 |
Device Name: | TruSculpt ID |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Cutera Inc. 3240 Bayshore Blvd. Brisbane, CA 94005 |
Contact | Amogh Kothare |
Correspondent | Amogh Kothare Cutera Inc. 3240 Bayshore Blvd. Brisbane, CA 94005 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-05-16 |
Decision Date | 2022-07-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TRUSCULPT ID 97109619 not registered Live/Pending |
Cutera, Inc. 2021-11-04 |