The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Trusculpt Rf Device; Trusculpt; Trusculpt 3d.
| Device ID | K180709 |
| 510k Number | K180709 |
| Device Name: | TruSculpt RF Device; TruSculpt; TruSculpt 3D |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | Cutera, Inc. 3240 Bayshore Blvd. Brisbane, CA 94005 |
| Contact | Brad Renton |
| Correspondent | Raymond Lee Cutera, Inc. 3240 Bayshore Blvd. Brisbane, CA 94005 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-19 |
| Decision Date | 2018-06-06 |
| Summary: | summary |