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EmPowerRF platform

FDA UDI

Class II (US FDA UDI)

by Inmode MD , Ltd.

Identity

Trade Name
EmPowerRF platform FDA UDI
Generic Name
Multi-modality skin surface treatment system FDA UDI
Device Name
InMode RF Pro system with the non-invasive applicators employs RF energy for various applications: • i-Forma, Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation. • WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids. • BodyFX™ (WMBody)/MiniFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite. The InMode RF Pro System with the Fractional Applicators employs RF energy for various applications: • Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. • Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV • Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV FDA UDI
Model / Reference
AG609933A FDA UDI
Description
InMode RF Pro system with the non-invasive applicators employs RF energy for various applications: • i-Forma, Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation. • WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids. • BodyFX™ (WMBody)/MiniFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite. The InMode RF Pro System with the Fractional Applicators employs RF energy for various applications: • Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. • Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV • Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV FDA UDI

Identifiers

Catalog Number
AG609933A FDA UDI
Primary DI / UDI-DI
07290016633702 FDA UDI
510(k) Number
K201150 FDA UDI
K210492 FDA UDI
FDA Product Code
GEI FDA UDI
PBX FDA UDI
ISA FDA UDI
NUV FDA UDI
GMDN Term
Multi-modality skin surface treatment system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
890.5660 FDA UDI
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

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

Similar devices

Also classified as Multi-modality skin surface treatment system.

Cleared under the same submission

K201150 also covers:

K210492 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 236c4694-d803-4ed7-9b23-b3353e0040f6 37 fields · synced May 30, 2026