The following data is part of a premarket notification filed by Microlight Corporation Of America with the FDA for Ml830 Laser System.
| Device ID | K041364 |
| 510k Number | K041364 |
| Device Name: | ML830 LASER SYSTEM |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | MICROLIGHT CORPORATION OF AMERICA 1401 MCKINNEY ST. SUITE 1900 Houston, TX 77010 |
| Contact | Fred A Simpson |
| Correspondent | Fred A Simpson MICROLIGHT CORPORATION OF AMERICA 1401 MCKINNEY ST. SUITE 1900 Houston, TX 77010 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-21 |
| Decision Date | 2004-12-13 |
| Summary: | summary |