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FDA 510(k)

LUTRONIC GENIUS

K-Number: K253484 · 2026-06-29

ApplicantCynosure Lutronic Technology Corporation
Decision Date2026-06-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUTRONIC GENIUS is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure Lutronic Technology Corporation. It received FDA 510(k) clearance on 2026-06-29 under 510(k) number K253484. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUTRONIC GENIUS?

LUTRONIC GENIUS is a medical device that received FDA 510(k) clearance on 2026-06-29. The listed applicant is Cynosure Lutronic Technology Corporation. The 510(k) number is K253484.

When did LUTRONIC GENIUS receive FDA 510(k) clearance?

LUTRONIC GENIUS received FDA 510(k) clearance on 2026-06-29, under 510(k) number K253484.

Who is the listed applicant for LUTRONIC GENIUS?

The FDA 510(k) record lists Cynosure Lutronic Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUTRONIC GENIUS?

The FDA product code for LUTRONIC GENIUS is GEI.

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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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