The following data is part of a premarket notification filed by Medicam Inc. with the FDA for Medicam Evolux, Evostar, Evolight And Evolase Pulsed Light System.
| Device ID | K111350 |
| 510k Number | K111350 |
| Device Name: | MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | MEDICAM INC. 7900 JEAN-BRILLON Montreal, Quebec, CA H8n 2l5 |
| Contact | Philippe Amar |
| Correspondent | Philippe Amar MEDICAM INC. 7900 JEAN-BRILLON Montreal, Quebec, CA H8n 2l5 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-13 |
| Decision Date | 2011-09-29 |
| Summary: | summary |