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InMode

FDA UDI

Class II (US FDA UDI)

by Inmode MD , Ltd.

Identity

Trade Name: InMode FDA UDI
Generic Name: Multi-modality skin surface treatment system FDA UDI
Device Name: InMode System 2 - color 1 Optimas FDA UDI
Model / Reference: AG606991A FDA UDI
Description: InMode System 2 - color 1 Optimas FDA UDI

Identifiers

Catalog Number: AG606991A FDA UDI
Primary DI / UDI-DI: 07290016633375 FDA UDI
510(k) Number: K123682 FDA UDI
K131362 FDA UDI
K140926 FDA UDI
K151273 FDA UDI
K160329 FDA UDI
K170738 FDA UDI
K172302 FDA UDI
K173677 FDA UDI
K180189 FDA UDI
K180719 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Multi-modality skin surface treatment system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 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: Multi-modality skin surface treatment system

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

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Also classified as Multi-modality skin surface treatment system.

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Cleared under the same submission

K123682 also covers:

Diolaze — Inmode MD , Ltd.
InMode — Inmode MD , Ltd.

K131362 also covers:

BodyFX — Inmode MD , Ltd.
Contoura - InMode RF™ — Inmode MD , Ltd.

K140926 also covers:

Contoura - InMode RF™ — Inmode MD , Ltd.
Forma — Inmode MD , Ltd.

K151273 also covers:

Contoura - InMode RF™ — Inmode MD , Ltd.
FRF — Inmode MD , Ltd.
FRF — Inmode MD , Ltd.

K160329 also covers:

Contoura - InMode RF™ — Inmode MD , Ltd.
MiniFX — Inmode MD , Ltd.

K170738 also covers:

K172302 also covers:

Contoura - InMode RF™ — Inmode MD , Ltd.

K173677 also covers:

InMode — Inmode MD , Ltd.
VLaze Applicator — Inmode MD , Ltd.

K180189 also covers:

K180719 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 0f91c578-d488-4039-bcc5-c6e8114aa083 37 fields · synced May 31, 2026