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Venus Freeze (MP)2 System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111670

by Venus Concept Ltd

Identifiers

510(k) Number
K111670 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Venus Freeze (MP)2 System is a non-invasive medical device classified under the product code GEI (General, Plastic Surgery). It is designed for dermatologic and general surgical procedures, specifically for the non-invasive treatment of moderate to severe facial wrinkles and rhytides. This device employs cryotherapy principles to address skin texture and aging concerns without surgical intervention. Its primary function is to deliver controlled freezing temperatures to targeted skin areas, promoting tissue remodeling and collagen stimulation.

The Venus Freeze (MP)2 System is supplied as a reusable medical device and is intended for use in clinical settings such as dermatology clinics or plastic surgery offices. It operates under sterile conditions, with disposable applicators provided for single-use applications to maintain hygiene. The device is not MRI-safe and must be used in accordance with manufacturer guidelines to ensure proper functionality and patient safety. Authorized for use in the United States under FDA 510(k) clearance (K111670), it adheres to regulatory standards for non-invasive cosmetic treatments.

Frequently asked questions

What types of skin concerns is the Venus Freeze (MP)2 System specifically designed to treat, and how does it work?

The Venus Freeze (MP)2 System is designed for non-invasive treatment of moderate to severe facial wrinkles and rhytides, as well as skin texture and aging concerns. It uses cryotherapy—controlled freezing temperatures—to stimulate tissue remodeling and collagen production, effectively improving skin appearance without surgery. The device targets specific skin areas to promote natural rejuvenation.

Is the Venus Freeze (MP)2 System reusable, and how is it maintained for clinical use?

Yes, the Venus Freeze (MP)2 System itself is a reusable medical device intended for use in clinical settings like dermatology clinics or plastic surgery offices. To maintain sterility and hygiene, it is paired with disposable applicators for single-use applications, ensuring each patient treatment remains safe and contamination-free. Follow manufacturer guidelines for cleaning and maintenance of the reusable components.

Are there different sizes or models of the Venus Freeze (MP)2 System, and how would I know which one to choose?

The provided data does not specify distinct sizes or models of the Venus Freeze (MP)2 System beyond its core design for facial wrinkles and rhytides. Selection would depend on clinical needs, such as treatment area size or patient-specific concerns. Consult the manufacturer’s documentation or a sales representative for guidance on applicator compatibility or additional accessories, as the system relies on disposable applicators for application.

Can the Venus Freeze (MP)2 System be used in environments with MRI machines, and what safety precautions should be taken?

No, the Venus Freeze (MP)2 System is not MRI-safe, meaning it should never be used in or near MRI environments. This is explicitly noted in the manufacturer’s guidelines to prevent interference or safety risks. Always ensure the device is operated in non-MRI areas and follow all safety protocols outlined by Venus Concept Ltd.

What regulatory pathway does the Venus Freeze (MP)2 System follow, and where was it originally cleared?

The Venus Freeze (MP)2 System was cleared through the FDA 510(k) pathway under the product code GEI (General, Plastic Surgery). It was originally submitted to the FDA on June 15, 2011, and received clearance on March 2, 2012, with the designation K111670. This clearance confirms its substantial equivalence to a predicate device for non-invasive dermatologic treatments in the United States.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VENUS CONCEPT MP2 USER MANUAL Pdf Download | ManualsLib, Venus Freeze MP 2 Operator Manual | Manualzz, Venus • einfach erklärt, Steckbrief, Temperatur · [mit Video], Venus concept MP2 Manuals | ManualsLib, PDF Venus Freeze User Manual - Acme Revival

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Venus Concept Ltd
FDA Applicant
Venus Concept , Ltd.

Sources (1)

  • FDA 510(k) K111670 24 fields · synced Sep 20, 2026