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Venus Legacy - 110V System

FDA UDI

Class II (US FDA UDI)

by Venus Concept Inc.

Identity

Trade Name
Venus Legacy - 110V System FDA UDI
Generic Name
Radio-frequency skin/body contouring system FDA UDI
Model / Reference
LE100004 FDA UDI

Identifiers

Primary DI / UDI-DI
07290016540086 FDA UDI
510(k) Number
K142910 FDA UDI
K143554 FDA UDI
K191528 FDA UDI
FDA Product Code
GEI FDA UDI
PBX 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radio-frequency skin/body contouring system

Venus Legacy - 110V System 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

K142910 also covers:

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 fc86244f-407a-4dbb-b717-c3e313424961 33 fields · synced Jun 1, 2026