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FDA 510(k)

Venus Versa PRO System

K-Number: K232192 · 2023-09-11

ApplicantVenus Concept, Inc.
Decision Date2023-09-11
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venus Versa PRO System is the device name listed in this FDA 510(k) record. The listed applicant is Venus Concept, Inc.. It received FDA 510(k) clearance on 2023-09-11 under 510(k) number K232192. 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 PRO System?

Venus Versa PRO System is a medical device that received FDA 510(k) clearance on 2023-09-11. The listed applicant is Venus Concept, Inc.. The 510(k) number is K232192.

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

Venus Versa PRO System received FDA 510(k) clearance on 2023-09-11, under 510(k) number K232192.

Who is the listed applicant for Venus Versa PRO System?

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

What is the FDA product code for Venus Versa PRO System?

The FDA product code for Venus Versa PRO System is ONF.

Other records listing Venus Concept, Inc. 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)K162765Venus Velocity Diode Laser SystemK153717Venus Versa SystemK152790Venus 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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