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FDA 510(k)

VENUS SWAN SYSTEM

K-Number: K111784 · 2011-10-07

ApplicantVenus Concept , Ltd.
Decision Date2011-10-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VENUS SWAN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Venus Concept , Ltd.. It received FDA 510(k) clearance on 2011-10-07 under 510(k) number K111784. 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 VENUS SWAN SYSTEM?

VENUS SWAN SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-07. The listed applicant is Venus Concept , Ltd.. The 510(k) number is K111784.

When did VENUS SWAN SYSTEM receive FDA 510(k) clearance?

VENUS SWAN SYSTEM received FDA 510(k) clearance on 2011-10-07, under 510(k) number K111784.

Who is the listed applicant for VENUS SWAN SYSTEM?

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

What is the FDA product code for VENUS SWAN SYSTEM?

The FDA product code for VENUS SWAN SYSTEM is GEI.

Related Clinical Trials

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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Other records listing Venus Concept , Ltd. as applicant

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.

K162765Venus Velocity Diode Laser SystemK153717Venus Versa SystemK152790Venus Versa SystemK111670VENUS FREEZE (MP)2 SYSTEMK100586VENUS FREEZE SYSTEM

Related Devices (Code: GEI)

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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