AccessGUDID - DEVICE: FAQ 101 (07640260120037)

GUDID

Device Identifier (DI) Information

Brand Name: FAQ 101
Version or Model: Amethyst
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Foreo AB

Primary DI Number: 07640260120037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 352394143 *Terms of Use

Device Description: FAQ™ 101 device is an over-the-counter home use devices intended for non-invasive treatments of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI.

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?
44832	Multi-modality skin contouring system	An assembly of devices that uses a combination of energies to temporarily minimize the manifestation of cellulite and loose or wrinkled skin. It typically consists of an applicator attached to an energy-producing generator and possibly other components. The applicator is applied to the body and may emit radio-frequency [typically in the bands of 1 megahertz (MHz)], infrared light, and/or other forms of energy, to heat skin/subdermal tissues for the production of a smooth-skin appearance. Vacuum may also be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
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 [?]
K222012	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: 1f6b005c-018b-44de-92ac-a9d918502791
Public Version Date: March 11, 2024
Public Version Number: 1
DI Record Publish Date: March 01, 2024