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Fractora

FDA UDI

Class II (US FDA UDI)

by Inmode MD , Ltd.

Identity

Trade Name
FRACTORA FDA UDI
Generic Name
Radio-frequency skin surface treatment system applicator FDA UDI
Device Name
Fractora system FDA UDI
Model / Reference
AG601398A FDA UDI
Description
Fractora system FDA UDI

Identifiers

Catalog Number
AG601398A FDA UDI
Primary DI / UDI-DI
07290016633023 FDA UDI
510(k) Number
K102461 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Radio-frequency skin surface treatment system applicator 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

Yes

FDA UDI

Category: Radio-frequency skin surface treatment system applicator

Fractora 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 system applicator.

Cleared under the same submission

K102461 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 e0243689-a1c4-470e-9a68-41236bd2d766 37 fields · synced Jun 6, 2026