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FDA 510(k)

LUXTEC MLX LIGHT SOURCE

K-Number: K081477 · 2008-06-18

ApplicantIntegra Luxtec, Inc.
Decision Date2008-06-18
Product CodeFCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LUXTEC MLX LIGHT SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Integra Luxtec, Inc.. It received FDA 510(k) clearance on 2008-06-18 under 510(k) number K081477. The device is classified under product code FCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUXTEC MLX LIGHT SOURCE?

LUXTEC MLX LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 2008-06-18. The listed applicant is Integra Luxtec, Inc.. The 510(k) number is K081477.

When did LUXTEC MLX LIGHT SOURCE receive FDA 510(k) clearance?

LUXTEC MLX LIGHT SOURCE received FDA 510(k) clearance on 2008-06-18, under 510(k) number K081477.

Who is the listed applicant for LUXTEC MLX LIGHT SOURCE?

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

What is the FDA product code for LUXTEC MLX LIGHT SOURCE?

The FDA product code for LUXTEC MLX LIGHT SOURCE is FCW.

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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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