The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Cynosure Cellulaze Laser.
| Device ID | K102541 |
| 510k Number | K102541 |
| Device Name: | CYNOSURE CELLULAZE LASER |
| Classification | Laser, Cellulite Appearance |
| 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 | OYW |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-03 |
| Decision Date | 2012-01-26 |
| Summary: | summary |