The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Picosure Workstation.
| Device ID | K121346 |
| 510k Number | K121346 |
| Device Name: | PICOSURE WORKSTATION |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Contact | Irina Kulinets |
| Correspondent | Irina Kulinets CYNOSURE, INC. 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 | 2012-05-04 |
| Decision Date | 2012-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494100551 | K121346 | 000 |
| 10841494100022 | K121346 | 000 |
| 00841494100001 | K121346 | 000 |