The following data is part of a premarket notification filed by Usa Laser Biotech Inc. with the FDA for Lumina 1600, 3300 And 6600 Systems.
| Device ID | K052814 |
| 510k Number | K052814 |
| Device Name: | LUMINA 1600, 3300 AND 6600 SYSTEMS |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | USA LASER BIOTECH INC. 12101 CULLEN BLVD., # A Houston, TX 77047 |
| Contact | M. Joyce Heinrich |
| Correspondent | M. Joyce Heinrich USA LASER BIOTECH INC. 12101 CULLEN BLVD., # A 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 | 2005-10-04 |
| Decision Date | 2005-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057949170181 | K052814 | 000 |
| 08057949170280 | K052814 | 000 |