FDA 510(k)

ReBorn (1050nm)

Número K: K233962 · 2024-04-16

Data da decisão2024-04-16

Código do produtoPKT

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ReBorn (1050nm) is the device name listed in this FDA 510(k) record. The listed applicant is Lightfective , Ltd.. It received FDA 510(k) clearance on 2024-04-16 under 510(k) number K233962. The device is classified under product code PKT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ReBorn (1050nm)?

ReBorn (1050nm) is a medical device that received FDA 510(k) clearance on 2024-04-16. The listed applicant is Lightfective , Ltd.. The 510(k) number is K233962.

When did ReBorn (1050nm) receive FDA 510(k) clearance?

ReBorn (1050nm) received FDA 510(k) clearance on 2024-04-16, under 510(k) number K233962.

Who is the listed applicant for ReBorn (1050nm)?

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

What is the FDA product code for ReBorn (1050nm)?

The FDA product code for ReBorn (1050nm) is PKT.

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