The following data is part of a premarket notification filed by Usa Laser Biotech Inc. with the FDA for Lumix Cps 1 Ir Lamp System Lumix Cps 2 Ir Lamp System Lumix Cps 3 Ir Lamp System Lumix Cps 4 Ir Lamp System Lumix Cps 5 Ir Lamp System.
| Device ID | K160947 |
| 510k Number | K160947 |
| Device Name: | LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | USA LASER BIOTECH INC. 9210 FOREST HILL AVENUE SUITE B-3 Richmond, VA 23235 |
| Contact | Nelson Marquina |
| Correspondent | M. Joyce Heinrich TEXAS APPLIED BIOMEDICAL SERVICES, INC. 1201 CULLEN BOULEVARD #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 | 2016-04-05 |
| Decision Date | 2016-07-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057949171645 | K160947 | 000 |
| 08057949171690 | K160947 | 000 |