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Venus Legacy kit

FDA UDI

Class II (US FDA UDI)

by Venus Concept Inc.

Identity

Trade Name
Venus Legacy kit FDA UDI
Generic Name
Radio-frequency skin/body contouring system FDA UDI
Device Name
Venus Legacy system and applicators FDA UDI
Model / Reference
PK000002 FDA UDI
Description
Venus Legacy system and applicators FDA UDI

Identifiers

Primary DI / UDI-DI
07290016540116 FDA UDI
510(k) Number
K143554 FDA UDI
K191528 FDA UDI
FDA Product Code
PBX FDA UDI
GEI FDA UDI
GMDN Term
Radio-frequency skin/body contouring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radio-frequency skin/body contouring system

Venus Legacy kit by Venus Concept Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radio-frequency skin/body contouring system.

Cleared under the same submission

K143554 also covers:

K191528 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Venus Concept Inc.

Sources (1)

  • FDA UDI c3d393d6-99d4-447a-ae03-3fd37398c2b0 34 fields · synced May 30, 2026