Faq 102

FDA UDI

Class II (US FDA UDI)

by Foreo Inc

Identity

Trade Name: FAQ 102 FDA UDI
Generic Name: Radio-frequency skin/body contouring system FDA UDI
Device Name: FAQ™ 102 devices are over-the-counter home use devices intended for facial and neck skin stimulation, and non-invasive treatments of mild to moderate facial wrinkles for adult women with all skin tones. FDA UDI
Model / Reference: Pink Ruby FDA UDI
Description: FAQ™ 102 devices are over-the-counter home use devices intended for facial and neck skin stimulation, and non-invasive treatments of mild to moderate facial wrinkles for adult women with all skin tones. FDA UDI

Identifiers

Primary DI / UDI-DI: 07640260120044 FDA UDI
510(k) Number: K240616 FDA UDI
FDA Product Code: NFO FDA UDI
PAY FDA UDI
OHS FDA UDI
GMDN Term: Radio-frequency skin/body contouring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5890 FDA UDI
878.4420 FDA UDI
878.4810 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radio-frequency skin/body contouring system

Faq 102 by Foreo Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K240616 also covers:

FAQ 102 — FOREO INC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Foreo Inc

Sources (1)

FDA UDI 5f4e3cf0-3d5a-4a4a-905e-f94e1a08cfdc 34 fields · synced May 30, 2026