The following data is part of a premarket notification filed by Cynosure Llc with the FDA for Tempsure System.
| Device ID | K200241 |
| 510k Number | K200241 |
| Device Name: | TempSure System |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | Cynosure LLC 5 Carlisle Road Westford, MA 01886 |
| Contact | Kevin O'connell |
| Correspondent | Kevin O'connell Cynosure LLC 5 Carlisle Road Westford, MA 01886 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-31 |
| Decision Date | 2020-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494108564 | K200241 | 000 |
| 00841494108533 | K200241 | 000 |
| 00841494108519 | K200241 | 000 |
| 00841494108441 | K200241 | 000 |
| 00841494108427 | K200241 | 000 |
| 00841494108410 | K200241 | 000 |
| 00841494108403 | K200241 | 000 |