The following data is part of a premarket notification filed by Usa Laser Biotech Inc. with the FDA for Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3.
| Device ID | K161198 |
| 510k Number | K161198 |
| Device Name: | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 |
| 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 | 2016-04-28 |
| Decision Date | 2016-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057949171782 | K161198 | 000 |
| 08057949171577 | K161198 | 000 |
| 08057949171584 | K161198 | 000 |
| 08057949171591 | K161198 | 000 |
| 08057949171607 | K161198 | 000 |
| 08057949171614 | K161198 | 000 |
| 08057949171621 | K161198 | 000 |
| 08057949171638 | K161198 | 000 |
| 08057949171751 | K161198 | 000 |
| 08057949171768 | K161198 | 000 |
| 08057949171775 | K161198 | 000 |
| 08057949171560 | K161198 | 000 |