The following data is part of a premarket notification filed by Cynosure, Inc. Dba Ellman with the FDA for Cortex Laser System.
| Device ID | K150587 |
| 510k Number | K150587 |
| Device Name: | Cortex Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Cynosure, Inc. Dba Ellman 400 Karin Lane Hicksville, NY 11801 |
| Contact | Allison Sathe |
| Correspondent | Allison Sathe Cynosure, Inc. Dba Ellman 400 Karin Lane Hicksville, NY 11801 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-09 |
| Decision Date | 2015-07-21 |
| Summary: | summary |