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Venus Concept USA, Inc.

United StatesFDA applicant, unverified

Devices
11

What Venus Concept USA, Inc. makes

Venus Concept USA, Inc. manufactures radiofrequency (RF) medical devices for non-surgical skin tightening and treatment, including the Venus Bliss, Venus BlissMAX, and Venus Viva series. Their portfolio also includes the Venus Epileve for targeted skin rejuvenation and the AI.ME System for AI-assisted treatment planning. Legacy devices like the Legacy BX and Venus Legacy Pro Device are designed for similar RF-based cosmetic procedures.

The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. Their products are intended for use in the United States, where they comply with FDA requirements for radiofrequency-based medical devices.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue11

Newest first, rows 1-11 of 11

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  • Venus Bliss Ref K190743

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Venus Viva MD Device Ref K201164

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Venus BlissMAX Ref K220592

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Family of Venus RF Systems - Heal Ref K182094

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Venus Epileve Ref K200786

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Venus BlissMAX Ref K213308

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Venus VivaTM Ref K191065

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Legacy BX Ref K142910

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Venus Legacy Pro Device Ref K191528

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Family of Venus RF Systems - Venus Freedom Ref K211461

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • AI.ME System Ref K221011

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-11 of 11

Frequently asked questions

How many devices does Venus Concept USA, Inc. have in the registry?

The registry currently lists 11 devices for Venus Concept USA, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Venus Concept USA, Inc.'s devices?

Among its 11 most recently registered devices, Venus Concept USA, Inc. has devices listed in FDA 510(k) (11 devices).

What risk classes do Venus Concept USA, Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Venus Concept USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Venus Concept USA, Inc. in the registry?

The most recently registered devices listed for Venus Concept USA, Inc. include Venus Bliss, Venus Viva MD Device, Venus BlissMAX and Family of Venus RF Systems - Heal.

Generated automatically from registry data and not verified by a human reviewer.