Identifiers
- 510(k) Number
- K140629 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 Swan (MP)2 is a medical device classified under regulation number 878.4400. It is categorized under product code GEI within the general and plastic surgery medical specialty.
This device received FDA 510(k) clearance on June 25, 2014, under K140629. It is manufactured by Venus Concept Ltd. and is subject to the regulatory requirements associated with its traditional clearance type.
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: K140629 FDA 510 (k) - VENUS SWAN (MP)2 | Venus Concept , Ltd., VENUS SWAN(MP)2 510(k) K140629 - FDA.report, Venus Swan (Mp)2 - Beudamed, VENUS CONCEPT MP2 USER MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140629 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Venus Concept Ltd
- FDA Applicant
- Venus Concept , Ltd.
Sources (1)
- FDA 510(k) K140629 24 fields · synced Sep 26, 2026