The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Cynosure Yag Family Laser.
Device ID | K072484 |
510k Number | K072484 |
Device Name: | CYNOSURE YAG FAMILY LASER |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-04 |
Decision Date | 2007-12-27 |