The following data is part of a premarket notification filed by Medical Laser Systems Inc with the FDA for Luminex Ll Laser System.
| Device ID | K063574 |
| 510k Number | K063574 |
| Device Name: | LUMINEX LL LASER SYSTEM |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | MEDICAL LASER SYSTEMS INC 800 CONNECTICUT AVE. NW SUITE 500 Wahington, DC 20006 |
| Contact | Miki Kolton |
| Correspondent | Miki Kolton MEDICAL LASER SYSTEMS INC 800 CONNECTICUT AVE. NW SUITE 500 Wahington, DC 20006 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-29 |
| Decision Date | 2007-01-29 |
| Summary: | summary |