Fynelook

Basic Information

• Brand Name: Fynelook
• Primary DI: 06979082450000
• Version / Model: EE0101
• Company Name: Shenzhen Dachi communication Co.,Ltd
• Labeler DUNS: 420650337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-02
• Public Version: 1
• Public Version Date: 2025-12-10
• Public Version Status: New
• Public Device Record Key: 7d9bcc58-08c6-4d4d-adcc-90c58d6e005f

Device Description

The Microcurrent Facial Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, membrane cloth, conductive gel and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	882.5890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06979082450000	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K244004	000