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FDA 510(k)

CYNOSURE CELLULAZE LASER

K-Number: K102541 · 2012-01-26

ApplicantCynosure, Inc.
Decision Date2012-01-26
Product CodeOYW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CYNOSURE CELLULAZE 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 2012-01-26 under 510(k) number K102541. The device is classified under product code OYW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYNOSURE CELLULAZE LASER?

CYNOSURE CELLULAZE LASER is a medical device that received FDA 510(k) clearance on 2012-01-26. The listed applicant is Cynosure, Inc.. The 510(k) number is K102541.

When did CYNOSURE CELLULAZE LASER receive FDA 510(k) clearance?

CYNOSURE CELLULAZE LASER received FDA 510(k) clearance on 2012-01-26, under 510(k) number K102541.

Who is the listed applicant for CYNOSURE CELLULAZE 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 CYNOSURE CELLULAZE LASER?

The FDA product code for CYNOSURE CELLULAZE LASER is OYW.

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Other records listing Cynosure, Inc. as applicant

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Related Devices (Code: OYW)

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.

K123407CELLULAZE LASERCynosure, Inc.

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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