The following data is part of a premarket notification filed by Lasermatic Oy with the FDA for Lasermatic Surgilaser Model 5050.
| Device ID | K870587 |
| 510k Number | K870587 |
| Device Name: | LASERMATIC SURGILASER MODEL 5050 |
| Classification | Laser, Ent Microsurgical Carbon-dioxide |
| Applicant | LASERMATIC OY LEPOLANTIE 21 SF-00660 HELSINKI Finland, FI |
| Contact | Esa Viherkoski |
| Correspondent | Esa Viherkoski LASERMATIC OY LEPOLANTIE 21 SF-00660 HELSINKI Finland, FI |
| Product Code | EWG |
| CFR Regulation Number | 874.4500 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-10 |
| Decision Date | 1988-08-10 |