LUMIWAVE 1X4 INFRARED THERAPY DEVICE
FDA 510(k) clearance K051816 · decided 2005-08-26
Clearance details
- K-number
- K051816
- Device name
- LUMIWAVE 1X4 INFRARED THERAPY DEVICE
- Applicant
- Biocare Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-05
- Decision date
- 2005-08-26
- Days to decision
- 52 days
- Clearance type
- Special
- Product code
- ILY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Denver, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc. recall (Z-1419-06) | Biocare Systems Inc. | 2006-08-24 |