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FDA 510(k)

ReBorn (1050nm)

K-Number: K233962 · 2024-04-16

ApplicantLightfective , Ltd.
Decision Date2024-04-16
Product CodePKT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the ReBorn (1050nm)?

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

When was ReBorn (1050nm) approved by the FDA?

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

What company makes ReBorn (1050nm)?

ReBorn (1050nm) is manufactured by Lightfective , Ltd..

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

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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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