Emvera

Basic Information

• Brand Name: Emvera
• Primary DI: 00863267000318
• Version / Model: Diolux Hand piece
• Company Name: EMVERA TECHNOLOGIES, LLC
• Labeler DUNS: 079501638
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-28
• Public Version: 4
• Public Version Date: 2023-06-19
• Public Version Status: Update
• Public Device Record Key: 7586cd79-6d20-44fc-9266-5f6d20cee78f

Device Description

Hand piece to be used with the Emvera Diolux Hair Removal Laser

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: 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
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58786	Dermatological diode laser system	A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam designed to perform dermatological procedures such as body hair removal (e.g., armpit, leg/arm, back, chest, bikini line, and face) and/or skin resurfacing (e.g., treatment of benign lesions, wrinkle reduction). It is intended to be used by a trained professional to emit pulsed light of a specific wavelength (e.g., around 808 nm or 1060 nm), delivered by a dedicated handpiece. It typically includes a control unit with dedicated software and user interface, delivery handpiece, and footswitch.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00863267000318	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K123257	000