The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Cynosure Dls-10-810 Diode Laser General Photocoagulator.
| Device ID | K970243 |
| 510k Number | K970243 |
| Device Name: | CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR |
| 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 | 1997-01-22 |
| Decision Date | 1997-06-03 |