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FDA 510(k)

MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM

K-Number: K111350 · 2011-09-29

ApplicantMedicam, Inc.
Decision Date2011-09-29
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medicam, Inc.. It received FDA 510(k) clearance on 2011-09-29 under 510(k) number K111350. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM?

MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-29. The listed applicant is Medicam, Inc.. The 510(k) number is K111350.

When did MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM receive FDA 510(k) clearance?

MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM received FDA 510(k) clearance on 2011-09-29, under 510(k) number K111350.

Who is the listed applicant for MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM?

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

What is the FDA product code for MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM?

The FDA product code for MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM is ONF.

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Related Devices (Code: ONF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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