SculpSure
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
CYNOSURE, INC.
The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Sculpsure.
Pre-market Notification Details
| Device ID | K150230 |
| 510k Number | K150230 |
| Device Name: | SculpSure |
| Classification | Laser For Disruption Of Adipocyte Cells For Aesthetic Use |
| Applicant | CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Contact | Kevin O'connell |
| Correspondent | Kevin O'connell CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Product Code | PKT |
| CFR Regulation Number | 878.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-02 |
| Decision Date | 2015-05-15 |
| Summary: | summary |
Trademark Results [SculpSure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SCULPSURE 86964533 5283577 Live/Registered |
CYNOSURE, LLC 2016-04-05 |
 SCULPSURE 86383950 4882549 Live/Registered |
CYNOSURE, LLC 2014-09-03 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.