The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Apogee Elite.
Device ID | K034030 |
510k Number | K034030 |
Device Name: | APOGEE ELITE |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-12-29 |
Decision Date | 2004-02-09 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
APOGEE ELITE 76649883 3226431 Dead/Cancelled |
CYNOSURE, INC. 2005-11-07 |