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LB1 applicator

FDA UDI

Class II (US FDA UDI)

by Venus Concept Inc.

Identity

Trade Name
LB1 applicator FDA UDI
Generic Name
Radio-frequency skin contouring system applicator, bipolar FDA UDI
Device Name
The Venus Legacy device is intended for the treatment of the following medical conditions; using the applicators for delivery of non-thermal RF combined with massage and magnetic field pulses: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite FDA UDI
Model / Reference
AS100006 FDA UDI
Description
The Venus Legacy device is intended for the treatment of the following medical conditions; using the applicators for delivery of non-thermal RF combined with massage and magnetic field pulses: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite FDA UDI

Identifiers

Primary DI / UDI-DI
07290016540024 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 contouring system applicator, bipolar 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

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

No

FDA UDI

Category: Radio-frequency skin contouring system applicator, bipolar

LB1 applicator by Venus Concept Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radio-frequency skin contouring system applicator, bipolar.

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 9ee752ae-9430-47a0-a95d-2d5b0f545cb8 34 fields · synced Jun 1, 2026