The following data is part of a premarket notification filed by Weck Surgical Systems with the FDA for 25 Watt Carbon Dioxide Medical Laser For Neurology.
| Device ID | K864166 |
| 510k Number | K864166 |
| Device Name: | 25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY |
| Classification | Laser, Neurosurgical |
| Applicant | WECK SURGICAL SYSTEMS 686 OLD WILLETS PATH Hauppauge, NY 11788 |
| Contact | Zbigniew Drozdowicz |
| Correspondent | Zbigniew Drozdowicz WECK SURGICAL SYSTEMS 686 OLD WILLETS PATH Hauppauge, NY 11788 |
| Product Code | LKW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-23 |
| Decision Date | 1987-02-10 |