EVOLUTION ST350

Basic Information

• Brand Name: EVOLUTION ST350
• Primary DI: 00667259003970
• Version / Model: 411103
• Company Name: Silhouet-Tone Corporation
• Labeler DUNS: 242049828
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-09
• Public Version: 1
• Public Version Date: 2025-07-17
• Public Version Status: New
• Public Device Record Key: e576f413-15c6-4740-9813-21c60d9d2209

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
38798	Hair-removal electrolysis system needle electrode, reusable	A device designed as a needle-shaped electrode used together with a hair-removal electrolysis system and used to destroy the dermal papilla (hair root) through application of an electric current from the parent device via the tip of this device that is inserted close to the hair shaft, under the skin, and into the dermal papilla. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00667259003970	GS1

Customer Contacts

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