The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Revlite Q-switched Nd:yag Laser System.
| Device ID | K133254 |
| 510k Number | K133254 |
| Device Name: | REVLITE Q-SWITCHED ND:YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Contact | Huda Yusuf |
| Correspondent | Huda Yusuf 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 | 2013-10-22 |
| Decision Date | 2014-03-05 |
| Summary: | summary |