The following data is part of a premarket notification filed by Medical Laser Technologies Ltd. with the FDA for Mlt R694 Ruby Laser System.
| Device ID | K980187 |
| 510k Number | K980187 |
| Device Name: | MLT R694 RUBY LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEDICAL LASER TECHNOLOGIES LTD. UNIT 4,BELLEKNOWES INDUSTRIAL ESTATE Inverkeithing,fife, GB |
| Contact | David Hamilton |
| Correspondent | David Hamilton MEDICAL LASER TECHNOLOGIES LTD. UNIT 4,BELLEKNOWES INDUSTRIAL ESTATE Inverkeithing,fife, GB |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-20 |
| Decision Date | 1998-04-03 |
| Summary: | summary |