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Define System

FDA UDI

Class II (US FDA UDI)

by Inmode MD , Ltd.

Identity

Trade Name
Define System FDA UDI
Generic Name
Radio-frequency skin surface treatment/fat liquefaction system control unit FDA UDI
Device Name
The DEFINE System is designed to deliver non-thermal RF energy to the skin and subdermal fat. . FDA UDI
Model / Reference
AG612444A FDA UDI
Description
The DEFINE System is designed to deliver non-thermal RF energy to the skin and subdermal fat. . FDA UDI

Identifiers

Catalog Number
AG612444A FDA UDI
Primary DI / UDI-DI
07290016633573 FDA UDI
510(k) Number
K191855 FDA UDI
K242598 FDA UDI
FDA Product Code
NUV FDA UDI
ISA FDA UDI
GEI FDA UDI
PBX FDA UDI
GMDN Term
Radio-frequency skin surface treatment/fat liquefaction system control unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
890.5660 FDA UDI
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

Yes

FDA UDI

Category: Radio-frequency skin surface treatment/fat liquefaction system control unit

Define System by Inmode MD , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radio-frequency skin surface treatment/fat liquefaction system control unit.

Cleared under the same submission

K191855 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inmode MD , Ltd.

Sources (1)

  • FDA UDI 75490fe1-debe-42d8-9c64-537b8f2b6f9f 37 fields · synced May 30, 2026