The following data is part of a premarket notification filed by Lasermatic Oy with the FDA for Lasermatic Combolaser Model 5050.
| Device ID | K895279 |
| 510k Number | K895279 |
| Device Name: | LASERMATIC COMBOLASER MODEL 5050 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASERMATIC OY 45 WEST ST. SUITE 2 North Attleboro, MA 02760 |
| Contact | Fuller W Morton |
| Correspondent | Fuller W Morton LASERMATIC OY 45 WEST ST. SUITE 2 North Attleboro, MA 02760 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-24 |
| Decision Date | 1989-11-08 |