The following data is part of a premarket notification filed by Hgm Medical Laser Systems, Inc. with the FDA for Photcoagulator Kr-568 Laser Spectrum Elite K1.
| Device ID | K911104 |
| 510k Number | K911104 |
| Device Name: | PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 |
| Classification | Instrument, Catheter, Punch |
| Applicant | HGM MEDICAL LASER SYSTEMS, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Dennis Reigle |
| Correspondent | Dennis Reigle HGM MEDICAL LASER SYSTEMS, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Product Code | FEX |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-13 |
| Decision Date | 1991-06-11 |