The following data is part of a premarket notification filed by American Laser Corp. with the FDA for Bq/bm Integrated Laser Delivery System.
| Device ID | K990665 |
| 510k Number | K990665 |
| Device Name: | BQ/BM INTEGRATED LASER DELIVERY SYSTEM |
| Classification | Laser, Ophthalmic |
| Applicant | AMERICAN LASER CORP. 2417 SOUTH 3850 WEST Salt Lake City, UT 84120 |
| Contact | Daniel Hoefer |
| Correspondent | Daniel Hoefer AMERICAN LASER CORP. 2417 SOUTH 3850 WEST Salt Lake City, UT 84120 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-02 |
| Decision Date | 1999-05-17 |
| Summary: | summary |