Biosonic

Basic Information

• Brand Name: Biosonic
• Primary DI: 00860558000422
• Version / Model: Facial Sculpting
• Company Name: BIOSONIC TECHNOLOGIES LLC
• Labeler DUNS: 080676748
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-01
• Public Version: 5
• Public Version Date: 2018-08-21
• Public Version Status: Update
• Public Device Record Key: 882240b3-3605-429f-8c32-93db31b4e527

Device Description

Microcurrent Facial Sculpting

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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	00860558000422	GS1
Package	10605580000425	GS1		1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K130065	000