HOUVA 3 PHOTOTHERAPY SYSTEM
FDA 510(k) clearance K041212 · decided 2004-06-09
Clearance details
- K-number
- K041212
- Device name
- HOUVA 3 PHOTOTHERAPY SYSTEM
- Applicant
- National Biological Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-10
- Decision date
- 2004-06-09
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- FTC
- Device class
- 2
- Regulation number
- 878.4630
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Twinsburg, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10 cardb recall (Z-1309-2008) | National Biological Corp | 2008-08-28 |