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Ultraviolet Sun Tanning Lamp

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151674

by G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh

Identifiers

510(k) Number: K151674 FDA 510(k)
FDA Product Code: LEJ FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4635 FDA 510(k)
Regulation Number: 878.4635 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Ultraviolet Sun Tanning Lamp by G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh — Class II — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer: G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh

Sources (1)

FDA 510(k) K151674 24 fields · synced Jun 18, 2026