Identifiers
- 510(k) Number
- K150161 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 Viva SR Device is a non-invasive fractional radiofrequency system for dermatological ablation and resurfacing. It consists of a console and a handheld applicator with a detachable electrode tip containing an array of small pins. The device delivers RF energy through the pins to heat dermal layers while minimizing epidermal injury.
The Venus Viva SR Device is used in clinical settings by healthcare professionals. It is supplied as part of a system that includes a console and a handheld applicator. The device has received FDA 510(k) clearance with the product code GEI and is intended for dermatological applications.
Frequently asked questions
What clinical purpose does the Venus Viva SR Device serve?
It is designed for dermatological ablation and resurfacing, using fractional radiofrequency energy to heat the dermal layer and stimulate collagen remodeling while minimizing damage to the epidermis.
How is the Venus Viva SR Device supplied to users?
The system is provided as a complete package that includes a console, a handheld applicator, and a detachable electrode tip with an array of small pins, allowing clinicians to set up and operate the device in a clinical environment.
Is the Venus Viva SR Device intended for single‑use or reusable application?
The console and handheld applicator are reusable components, while the detachable electrode tip can be replaced as needed; the device is not marketed as a disposable, single‑use product.
What regulatory pathway did the Venus Viva SR Device follow?
It received FDA 510(k) clearance under the traditional review pathway, being deemed substantially equivalent to a predicate device with product code GEI.
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: K150161 FDA 510(k) - Venus Viva SR Device | Venus Concept , Ltd., Venus Viva SR Device (K150161) — FDA 510(k) | Innolitics, Venus Viva™ MD Skin Resurfacing System | Venus Concept
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150161 | Class II | Active |
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Manufacturer
- Manufacturer
- Venus Concept Ltd
- FDA Applicant
- Venus Concept , Ltd.
Sources (1)
- FDA 510(k) K150161 24 fields · synced Sep 27, 2026