AccessGUDID - DEVICE: FAQ 103 (07640260120051)

GUDID

Device Identifier (DI) Information

Brand Name: FAQ 103
Version or Model: Blak Diamond
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Foreo AB

Primary DI Number: 07640260120051
Issuing Agency: GS1
Commercial Distribution End Date: August 07, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 352394143 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45219	Radio-frequency skin/body contouring system	An assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
OHS	Light Based Over The Counter Wrinkle Reduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240616	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f4796f48-6ebe-4241-b368-3907900e3e4f
Public Version Date: June 30, 2025
Public Version Number: 4
DI Record Publish Date: July 18, 2024