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Dermalight Psoracomb

by Solitec GmbH

510(k) K903660

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK903660 Date17 Jul 1991ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1778-2013 FDA Class III initiated 9 Apr 2013 on shared 510(k) K903660

    The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.

    • Terminated Z-1779-2013 FDA Class III initiated 8 Apr 2013 on shared 510(k) K903660

    The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IOB
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

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