The following data is part of a premarket notification filed by Medical Laser Therapeutics Lp with the FDA for Mlt-1000 Ir Laser System.
| Device ID | K033986 |
| 510k Number | K033986 |
| Device Name: | MLT-1000 IR LASER SYSTEM |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | MEDICAL LASER THERAPEUTICS LP 12101-A CULLEN BLVD. Houston, TX 77047 |
| Contact | M. Joyce Heinrich |
| Correspondent | M. Joyce Heinrich MEDICAL LASER THERAPEUTICS LP 12101-A CULLEN BLVD. Houston, TX 77047 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-23 |
| Decision Date | 2004-03-29 |
| Summary: | summary |