The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Affirm With Xpl Handpiece And Er:yag Laser Module.
| Device ID | K080006 |
| 510k Number | K080006 |
| Device Name: | AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Contact | George Cho |
| Correspondent | George Cho CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-02 |
| Decision Date | 2008-02-28 |
| Summary: | summary |