The following data is part of a premarket notification filed by Cynosure, Inc with the FDA for Tempsure System.
| Device ID | K182365 |
| 510k Number | K182365 |
| Device Name: | TempSure System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Cynosure, Inc 5 Carlisle Road Westford, MA 01886 |
| Contact | Amy Tannenbaum |
| Correspondent | Amy Tannenbaum Cynosure, Inc 5 Carlisle Road Westford, MA 01886 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-30 |
| Decision Date | 2018-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494108397 | K182365 | 000 |
| 00841494108366 | K182365 | 000 |
| 00841494108069 | K182365 | 000 |