UV 8001K, PUVA 800, PUVA 180/200 1000
FDA 510(k) clearance K841795 · decided 1984-08-30
Clearance details
- K-number
- K841795
- Device name
- UV 8001K, PUVA 800, PUVA 180/200 1000
- Applicant
- Waldmann Lighting Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-05-02
- Decision date
- 1984-08-30
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- KGL
- Device class
- 2
- Regulation number
- 878.4630
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| WALDMANN F85/100W PUVA (K852575) | Sylvania Lighting Products | 1985-08-16 |
| SPECTRA 305/350 (K820280) | Ultralite | 1982-03-05 |
| HO-B-LITE VI UNIT (K810668) | National Biological Corp. | 1981-04-23 |
| PHOTOTHERAPY LIGHT CHAMBER (K810358) | Paul B. Elder Co. | 1981-03-20 |
| PSORALITE MARK I (K791977) | Paul B. Elder Co. | 1979-12-28 |
| PSORALITE SERIES 30,000 (K791116) | Paul B. Elder Co. | 1979-09-04 |
| UVA PHOTOTHERAPY SYSTEM (K761094) | Dermatron Corp. | 1976-12-02 |
Recalls involving this device
No recalls on record reference this clearance.