The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Affinity Qs Q-switched Nd:yag Laser System.
| Device ID | K050382 |
| 510k Number | K050382 |
| Device Name: | AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CYNOSURE, INC. 10 ELIZABETH DR. Chelmsford, MA 01824 |
| Contact | George Cho |
| Correspondent | George Cho CYNOSURE, INC. 10 ELIZABETH DR. Chelmsford, MA 01824 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-15 |
| Decision Date | 2005-09-14 |
| Summary: | summary |