The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Cynosure 1064nm Diode Laser.
| Device ID | K123971 |
| 510k Number | K123971 |
| Device Name: | CYNOSURE 1064NM DIODE LASER |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Contact | Irina Kulinets |
| Correspondent | Irina Kulinets CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-05-02 |
| Summary: | summary |