The following data is part of a premarket notification filed by Medical Laser Technologies Ltd. with the FDA for Mlt 30 Laser.
| Device ID | K982548 |
| 510k Number | K982548 |
| Device Name: | MLT 30 LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEDICAL LASER TECHNOLOGIES LTD. 23832 VIA MONTE Coto De Caza, CA 92679 -4001 |
| Contact | William Kelley |
| Correspondent | William Kelley MEDICAL LASER TECHNOLOGIES LTD. 23832 VIA MONTE Coto De Caza, CA 92679 -4001 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-21 |
| Decision Date | 1998-10-19 |
| Summary: | summary |