The following data is part of a premarket notification filed by Lasermatic, Inc. with the FDA for Combolaser Model 5050.
| Device ID | K893529 |
| 510k Number | K893529 |
| Device Name: | COMBOLASER MODEL 5050 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASERMATIC, INC. MEDICAL DEVICE CONSULTANTS INC 45 WEST STREERT, SUITE 2 Attleboro, MA 02703 |
| Contact | Toby Fuller |
| Correspondent | Toby Fuller LASERMATIC, INC. MEDICAL DEVICE CONSULTANTS INC 45 WEST STREERT, SUITE 2 Attleboro, MA 02703 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-08 |
| Decision Date | 1989-06-08 |