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510(k) K828671

UVATEC SUNTAMED 4000 AND 2000 by Solitec GmbH

K828671 is an FDA 510(k) premarket notification submitted by Solitec GmbH for the device "UVATEC SUNTAMED 4000 AND 2000". The FDA issued a decision of Substantially Equivalent on January 19, 1983. Solitec GmbH has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1983
Date Received
November 30, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Solitec GmbH

  • K903660 — DERMALIGHT PSORACOMB (July 17, 1991)
  • K828670 — UVATEC SUNTAMED 400 (January 17, 1983)

FDA data resources