AccessGUDID - DEVICE: Micro-current Facial Beauty Device (06976415770156)

GUDID

Device Identifier (DI) Information

Brand Name: Micro-current Facial Beauty Device
Version or Model: AM-810B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Shenzhen Aozemei Technology Co., Ltd.

Primary DI Number: 06976415770156
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 412088514 *Terms of Use

Device Description: Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild tomoderate inflammatory acne.(cleared under K241718) Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic useincluding facial and neck stimulation.

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?
61169	Transcutaneous electrical stimulation probe	A non-sterile, hand-held, pen-like electrical conductor intended to be held against a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation]. It typically has a metallic tip for skin contact, sometimes using a conductive pad. This is a reusable device.	Active	false
62202	Blue/red/infrared phototherapy lamp	A portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHS	Light Based Over The Counter Wrinkle Reduction
OLP	Over-The-Counter Powered Light Based Laser For Acne
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241718	000
K243430	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: 8278c703-1bf7-47da-a6c0-4eb3248837fd
Public Version Date: April 09, 2025
Public Version Number: 1
DI Record Publish Date: April 01, 2025