FDA 510(k)

LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))

Número K: K231555 · 2023-07-27

Data da decisão2023-07-27

Código do produtoOHS

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) is the device name listed in this FDA 510(k) record. The listed applicant is iSMART Developments, Ltd.. It received FDA 510(k) clearance on 2023-07-27 under 510(k) number K231555. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))?

LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) is a medical device that received FDA 510(k) clearance on 2023-07-27. The listed applicant is iSMART Developments, Ltd.. The 510(k) number is K231555.

When did LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) receive FDA 510(k) clearance?

LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) received FDA 510(k) clearance on 2023-07-27, under 510(k) number K231555.

Who is the listed applicant for LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))?

The FDA 510(k) record lists iSMART Developments, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))?

The FDA product code for LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) is OHS.

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