The following data is part of a premarket notification filed by Ultralight Laser Technologies, Llc with the FDA for Multilaser System.
| Device ID | K123777 |
| 510k Number | K123777 |
| Device Name: | MULTILASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ULTRALIGHT LASER TECHNOLOGIES, LLC 105 CITATION COURT Homewood, AL 35209 |
| Contact | Mark Rohrer |
| Correspondent | Mark Rohrer ULTRALIGHT LASER TECHNOLOGIES, LLC 105 CITATION COURT Homewood, AL 35209 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-10 |
| Decision Date | 2013-04-11 |
| Summary: | summary |