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FDA 510(k)

MILAN System

K-Number: K253803 · 2026-06-02

ApplicantLumenis Be, Ltd.
Decision Date2026-06-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MILAN System is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis Be, Ltd.. It received FDA 510(k) clearance on 2026-06-02 under 510(k) number K253803. 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 MILAN System?

MILAN System is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is Lumenis Be, Ltd.. The 510(k) number is K253803.

When did MILAN System receive FDA 510(k) clearance?

MILAN System received FDA 510(k) clearance on 2026-06-02, under 510(k) number K253803.

Who is the listed applicant for MILAN System?

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

What is the FDA product code for MILAN System?

The FDA product code for MILAN System is GEI.

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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.

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