The following data is part of a premarket notification filed by Medical Laser Systems Inc with the FDA for Luminex Infrared Lamp System.
| Device ID | K082969 |
| 510k Number | K082969 |
| Device Name: | LUMINEX INFRARED LAMP SYSTEM |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | MEDICAL LASER SYSTEMS INC 2101 L STREET NW Washington, DC 20037 |
| Contact | Miki Kolton |
| Correspondent | Miki Kolton MEDICAL LASER SYSTEMS INC 2101 L STREET NW Washington, DC 20037 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-06 |
| Decision Date | 2008-10-23 |
| Summary: | summary |