← Back to catalogue

Faq 103

FDA UDI

Class II (US FDA UDI)

by Foreo Inc

Identity

Trade Name
FAQ 103 FDA UDI
Generic Name
Radio-frequency skin/body contouring system FDA UDI
Device Name
FAQ™ 103 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
Blak Diamond FDA UDI
Description
FAQ™ 103 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
07640260120051 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
Not 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

No

FDA UDI

Over-the-Counter

Yes

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

Faq 103 by Foreo Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K240616 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Foreo Inc

Sources (1)

  • FDA UDI f4796f48-6ebe-4241-b368-3907900e3e4f 35 fields · synced Jun 1, 2026