The following data is part of a premarket notification filed by American Laser Medical with the FDA for Flex-lase 600 Series Ion Laser System.
| Device ID | K963389 |
| 510k Number | K963389 |
| Device Name: | FLEX-LASE 600 SERIES ION LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AMERICAN LASER MEDICAL 1832 SOUTH 3850 WEST Salt Lake City, UT 84104 |
| Contact | Danial Hoefer |
| Correspondent | Danial Hoefer AMERICAN LASER MEDICAL 1832 SOUTH 3850 WEST 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 | 1996-08-28 |
| Decision Date | 1996-11-26 |
| Summary: | summary |