EVOLUTION 7HD SEQUENTIAL

Basic Information

• Brand Name: EVOLUTION 7HD SEQUENTIAL
• Primary DI: 00667259003796
• Version / Model: 411017
• Company Name: Silhouet-Tone Corporation
• Labeler DUNS: 242049828
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-17
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 90e9fead-56be-4d44-859f-450025a2867a

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: Yes
• Has Serial Number: No
• 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
KCW	Epilator, High Frequency, Needle-Type	General, Plastic Surgery	878.5350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43642	Professional hair-removal electrolysis system	An assembly of devices intended to permanently remove unwanted body hair by destroying the dermal papilla (hair root) through application of an electric current at the tip of a fine needle electrode that is inserted close to the hair shaft, under the skin, and into the dermal papilla. It typically includes an electrically-powered control unit, a handpiece that connects to the control unit and holds the disposable electrode, and a foot-switch. The system is typically available in three types: galvanic (applies DC), thermolysis/high-frequency (applies AC), and blend (applies DC/AC combination). It is intended to be operated by a trained professional and may be referred to as an epilator.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00667259003796	GS1

Customer Contacts

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