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 | K171111 |
| 510k Number | K171111 |
| Device Name: | Sculpsure |
| Classification | Laser For Disruption Of Adipocyte Cells For Aesthetic Use |
| Applicant | Cynosure, Inc 5 Caelisle Road Westford, MA 01886 |
| Contact | Amy Tannenbaum |
| Correspondent | Amy Tannenbaum Cynosure, Inc 5 Caelisle 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 | 2017-04-14 |
| Decision Date | 2017-06-13 |
| 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 |
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