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FDA 510(k)

ALUMA SKIN RENEWAL SYSTEM

K-Number: K051214 · 2005-10-24

ApplicantLumenis, Inc.
Decision Date2005-10-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALUMA SKIN RENEWAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 2005-10-24 under 510(k) number K051214. 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 ALUMA SKIN RENEWAL SYSTEM?

ALUMA SKIN RENEWAL SYSTEM is a medical device that received FDA 510(k) clearance on 2005-10-24. The listed applicant is Lumenis, Inc.. The 510(k) number is K051214.

When did ALUMA SKIN RENEWAL SYSTEM receive FDA 510(k) clearance?

ALUMA SKIN RENEWAL SYSTEM received FDA 510(k) clearance on 2005-10-24, under 510(k) number K051214.

Who is the listed applicant for ALUMA SKIN RENEWAL SYSTEM?

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

What is the FDA product code for ALUMA SKIN RENEWAL SYSTEM?

The FDA product code for ALUMA SKIN RENEWAL 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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