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Philips Lumea IPL

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243453

by Philips Consumer Lifestyle B.V.

Identifiers

510(k) Number
K243453 FDA 510(k)
FDA Product Code
OHT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Philips Lumea IPL by Philips Consumer Lifestyle B.V. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K243453 24 fields · synced Sep 18, 2026