The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Q-11 Ophthalmic Laser.
| Device ID | K931499 |
| 510k Number | K931499 |
| Device Name: | Q-11 OPHTHALMIC LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Joseph Lambert |
| Correspondent | Joseph Lambert HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-25 |
| Decision Date | 1993-08-19 |