Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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.

Frequently Asked Questions

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.

Related Devices (Code: PKT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.K231971DEKA PHYSIQ 360El.En S.P.A.K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,LtdK222226EONDominion Aesthetic Technologies, Inc.K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,LtdK211681EONDominion Aesthetic Technologies, Inc.

Official Source

View on FDA Database →

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

↑