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FDA 510(k)

Venus Versa System

K-Number: K152790 · 2016-01-20

ApplicantVenus Concept , Ltd.
Decision Date2016-01-20
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venus Versa 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 2016-01-20 under 510(k) number K152790. 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 Venus Versa System?

Venus Versa System is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is Venus Concept , Ltd.. The 510(k) number is K152790.

When did Venus Versa System receive FDA 510(k) clearance?

Venus Versa System received FDA 510(k) clearance on 2016-01-20, under 510(k) number K152790.

Who is the listed applicant for Venus Versa 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 Versa System?

The FDA product code for Venus Versa System is ONF.

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.

K252845Venus Nova (FP-2001)K232192Venus Versa PRO SystemK162765Venus Velocity Diode Laser SystemK153717Venus Versa System

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.

K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.K231952MEDILIGHTMedicreations, LLCK243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA LOTUSEl.En S.P.A.K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.

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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