The following data is part of a premarket notification filed by Lasermatic, Inc. with the FDA for Modified Combolaser 5050 & New Model 5050 Ver. 33.
| Device ID | K901638 |
| 510k Number | K901638 |
| Device Name: | MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33 |
| 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 | 1990-04-09 |
| Decision Date | 1990-06-27 |