510(k) Report

FDA applicant

Solitec GmbH

Planegg, DE3 decisions1983–19912 recalls

FDA records 3 decisions for Solitec GmbH (Planegg, DE) from 1983 to 1991: 3 510(k) clearances. All are in product code IOB (Lamp, Infrared, Non Heating). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Solitec GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Solitec GmbH since 2007.

Recalls per year

2in 2013

2013: 2
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Solitec GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IOBLamp, Infrared, Non Heating1decision

What has FDA decided for it lately?

  • K903660Dermalight PsoracombSolitec GmbH · 19912 recalls
  • K828671Uvatec Suntamed 4000 and 2000Solitec GmbH · 1983
  • K828670Uvatec Suntamed 400Solitec GmbH · 1983

All 3 as Solitec GmbH →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K903660Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a…Apr 9, 2013Class III
  • K903660Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a…Apr 8, 2013Class III