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FDA 510(k)

ILUMINAGE DIODE LASER

K-Number: K111454 · 2012-07-05

ApplicantCynosure, Inc.
Decision Date2012-07-05
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ILUMINAGE DIODE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, Inc.. It received FDA 510(k) clearance on 2012-07-05 under 510(k) number K111454. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ILUMINAGE DIODE LASER?

ILUMINAGE DIODE LASER is a medical device that received FDA 510(k) clearance on 2012-07-05. The listed applicant is Cynosure, Inc.. The 510(k) number is K111454.

When did ILUMINAGE DIODE LASER receive FDA 510(k) clearance?

ILUMINAGE DIODE LASER received FDA 510(k) clearance on 2012-07-05, under 510(k) number K111454.

Who is the listed applicant for ILUMINAGE DIODE LASER?

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

What is the FDA product code for ILUMINAGE DIODE LASER?

The FDA product code for ILUMINAGE DIODE LASER is OHS.

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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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