The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Cynosure Photogenica T Tattoo Removal Laser.
Device ID | K923683 |
510k Number | K923683 |
Device Name: | CYNOSURE PHOTOGENICA T TATTOO REMOVAL LASER |
Classification | Powered Laser Surgical Instrument |
Applicant | CYNOSURE, INC. 35 WIGGINS AVE. Bedford, MA 01730 -2314 |
Contact | George Cho |
Correspondent | George Cho CYNOSURE, INC. 35 WIGGINS AVE. Bedford, MA 01730 -2314 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-23 |
Decision Date | 1992-10-15 |