AccessGUDID - DEVICE: PEACH 2 go (07350120791900)

GUDID

Device Identifier (DI) Information

Brand Name: PEACH 2 go
Version or Model: Peach
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Foreo AB

Primary DI Number: 07350120791900
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 352394143 *Terms of Use

Device Description: PEACH™ 2 go is an over-the-counter device intended for the removal of unwanted body hair and/or facial hair.

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?
65776	Home-use intense pulsed light hair removal unit	A hand-held, electrically-powered device designed to be used in the home to produce strong, controlled flashes of filtered light in the wavelength range of 400 - 1200nm [intense pulsed light (IPL)] for self-removal of unwanted hair.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHT	Light Based Over-The-Counter Hair Removal
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231977	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: a6e44d45-14ef-46f3-9364-362ef51a547a
Public Version Date: August 15, 2024
Public Version Number: 1
DI Record Publish Date: August 07, 2024