510(k) Report

510(k) · Cleared

Recalled · Class III · 2013

Dermalight Psoracomb

K903660510(k) TraditionalCleared Jul 17, 1991341-day reviewClass II21 CFR 890.5500Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Solitec GmbH · IOB Lamp, Infrared, Non Heating

Cleared on Jul 17, 1991 after a 341-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 2 times.

Decided
Jul 17, 1991
Review
341 days
Class
Class II
Product code
IOB
Recalls
2
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K903660Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 9, 2013Class IIIZ-1778-2013Labeling mix-upsThe incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.
Apr 8, 2013Class IIIZ-1779-2013Labeling mix-upsThe incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All IOB devices

IOB Lamp, Infrared, Non Heating: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IOB

FDA has decided no IOB device since 2007.

Median 510(k) review, days · IOB

Too few IOB 510(k)s in any year since 2007 to give a median.

Recalls per year · IOB

No recall names IOB since 2007.

Adverse event reports per year · IOB

No MAUDE report names IOB since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Solitec GmbH

3 FDA decisions under this applicant name. See the company

  • K828671Uvatec Suntamed 4000 and 2000Solitec GmbH · 1983
  • K828670Uvatec Suntamed 400Solitec GmbH · 1983

Recent decisions in IOB

The IOB category page

  • K910091Ultralite PaneliteUltralite · 1991
  • K842276SunmasterMt. Hood Mfr., Inc. · 1984
  • K813451Uva Fluorescent Tanning LampsNorth American Philips Corp. · 1982
  • K812853Osram Uva LampOsram GmbH · 1981
  • K760519Sunlamp, Flourescent Dermatron F40-313 and F20-313Dermatron Corp. · 1976

https://510kreport.com/device/K903660 · printed Nov 6, 2026

Cite this page

510(k) Report. “K903660: Dermalight Psoracomb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903660

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026