ULTRALITE PANELITE
FDA 510(k) clearance K910091 · decided 1991-05-30
Clearance details
- K-number
- K910091
- Device name
- ULTRALITE PANELITE
- Applicant
- Ultralite
- Decision
- Substantially Equivalent
- Date received
- 1991-01-09
- Decision date
- 1991-05-30
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- IOB
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Lawrenceville, GA, 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 |
|---|---|---|
| DERMALIGHT PSORACOMB (K903660) | Solitec GmbH | 1991-07-17 |
| SUNMASTER (K842276) | Mt. Hood Mfr., Inc. | 1984-07-16 |
| UVA FLUORESCENT TANNING LAMPS (K813451) | North American Philips Corp. | 1982-01-28 |
| OSRAM UVA LAMP (K812853) | Osram GmbH | 1981-12-09 |
| SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313 (K760519) | Dermatron Corp. | 1976-09-03 |
Recalls involving this device
No recalls on record reference this clearance.