The following data is part of a premarket notification filed by Hgm Medical Laser Systems, Inc. with the FDA for Model 20 Ky Krypton Yellow Laser.
| Device ID | K881940 |
| 510k Number | K881940 |
| Device Name: | MODEL 20 KY KRYPTON YELLOW LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HGM MEDICAL LASER SYSTEMS, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Bill Papworth |
| Correspondent | Bill Papworth HGM MEDICAL LASER SYSTEMS, 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 | 1988-05-09 |
| Decision Date | 1988-07-20 |