The following data is part of a premarket notification filed by Biocare Systems, Inc. with the FDA for Lumiwave 1x4 Infrared Therapy Device.
| Device ID | K051816 |
| 510k Number | K051816 |
| Device Name: | LUMIWAVE 1X4 INFRARED THERAPY DEVICE |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | BIOCARE SYSTEMS, INC. 518 17TH STREET SUITE 1350 Denver, CO 80202 |
| Contact | Clay Anselmo |
| Correspondent | Clay Anselmo BIOCARE SYSTEMS, INC. 518 17TH STREET SUITE 1350 Denver, CO 80202 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-05 |
| Decision Date | 2005-08-26 |
| Summary: | summary |