The following data is part of a premarket notification filed by Texas Applied Biomedical Services, Inc. with the FDA for Lumix 3 Plus And Lumix 3 Ultra System.
| Device ID | K132016 |
| 510k Number | K132016 |
| Device Name: | LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | TEXAS APPLIED BIOMEDICAL SERVICES, INC. 12101-A CULLEN BLVD. SUITE A Houston, TX 77047 |
| Contact | M. Joyce Heinrich |
| Correspondent | M. Joyce Heinrich TEXAS APPLIED BIOMEDICAL SERVICES, INC. 12101-A CULLEN BLVD. SUITE 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 | 2013-07-01 |
| Decision Date | 2014-06-02 |
| Summary: | summary |