DERMALIGHT PSORACOMB— 510(k) K903660
Substantially EquivalentSolitec GmbH
FDA 510(k) clearance K903660 for DERMALIGHT PSORACOMB, Substantially Equivalent on 1991-07-17. Applicant: Solitec GmbH. Device class: 2.
Clearance details
- Applicant
- Solitec GmbH
- Product code
- Code IOB
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Planegg, DE
Recent devices under product code IOB
view allMore clearances from Solitec GmbH
view allRecalls naming K903660
K-number listed on FDA's recall record- Z-1778-2013 — Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.
- Z-1779-2013 — Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K903660.
Data sourced from openFDA. This site is unofficial and independent of the FDA.