The following data is part of a premarket notification filed by Rohrer Aesthetics, Llc with the FDA for Picolazer Laser System.
| Device ID | K192583 |
| 510k Number | K192583 |
| Device Name: | PicoLazer Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Rohrer Aesthetics, LLC 105 Citation Court Homewood, AL 35209 |
| Contact | Mark Rohrer |
| Correspondent | Mark Rohrer Rohrer Aesthetics, 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 | 2019-09-19 |
| Decision Date | 2020-01-17 |