The following data is part of a premarket notification filed by Medical Laser Technologies, Llc with the FDA for Medical Laser Technologies, Llc Mtl Erbium:yag Laser System.
| Device ID | K032599 |
| 510k Number | K032599 |
| Device Name: | MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEDICAL LASER TECHNOLOGIES, LLC 516 SCOTT STREET Homewood, AL 35209 |
| Contact | Mark Rohrer |
| Correspondent | Mark Rohrer MEDICAL LASER TECHNOLOGIES, LLC 516 SCOTT STREET Homewood, AL 35209 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-25 |
| Decision Date | 2003-10-29 |
| Summary: | summary |