510(k) K903660
- Device
- DERMALIGHT PSORACOMB
- Applicant
- SOLITEC GMBH
- 510(k) number
- K903660
- Product code
- IOB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-07-17
- Date received
- 1990-08-10
- Regulation
- 890.5500
- Classification name
- Lamp, Infrared, Non Heating
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SCHIMD
- Address
- Fraunhoferstrasse 5 Planegg DE D-82152 D-82152
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IOB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K910091 | ULTRALITE PANELITE | Ultralite | 1991-05-30 |
| K842276 | SUNMASTER | Mt. Hood Mfr., Inc. | 1984-07-16 |
| K813451 | UVA FLUORESCENT TANNING LAMPS | North American Philips Corp. | 1982-01-28 |
| K812853 | OSRAM UVA LAMP | Osram GmbH | 1981-12-09 |
| K760519 | SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313 | Dermatron Corp. | 1976-09-03 |
Legacy Summary#
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FDA Review#
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