The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Cynosure Photogenica Vls-star.
Device ID | K000490 |
510k Number | K000490 |
Device Name: | CYNOSURE PHOTOGENICA VLS-STAR |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-15 |
Decision Date | 2000-03-13 |