The following data is part of a premarket notification filed by Cynosure, Llc with the FDA for Tempsure System.
| Device ID | K212891 |
| 510k Number | K212891 |
| Device Name: | TempSure System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Cynosure, LLC 5 Carlisle Road Westford, MA 01886 |
| Contact | Michael King |
| Correspondent | Michael King Cynosure, LLC 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 | 2021-09-10 |
| Decision Date | 2022-03-18 |