The following data is part of a premarket notification filed by Cynosure Llc with the FDA for Picosure Workstation.
| Device ID | K210226 |
| 510k Number | K210226 |
| Device Name: | PicoSure Workstation |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-28 |
| Decision Date | 2021-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494100537 | K210226 | 000 |
| 00841494100230 | K210226 | 000 |
| 00841494108090 | K210226 | 000 |