The following data is part of a premarket notification filed by Laser, Inc. with the FDA for Co2 Laser Coupler.
| Device ID | K983965 |
| 510k Number | K983965 |
| Device Name: | CO2 LASER COUPLER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASER, INC. 1803 BAKER DR. Tomball, TX 77375 -0434 |
| Contact | William K Przbybla |
| Correspondent | William K Przbybla LASER, INC. 1803 BAKER DR. Tomball, TX 77375 -0434 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-06 |
| Decision Date | 1998-12-22 |