VBeam Prima CC Delivery System

Basic Information

• Brand Name: VBeam Prima CC Delivery System
• Primary DI: 00817495023007
• Version / Model: 7123-00-0431
• Company Name: Candela Corporation
• Labeler DUNS: 053468385
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-12
• Public Version: 7
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: 6ac9c0e0-8664-4f20-b60b-293153f8a1b9

Device Description

Delivery System Assembly

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: 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: 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
65509	Dermatological laser beam producing handpiece	A hand-held component of a professional, high-powered, dermatological laser system designed to both generate and direct a therapeutic laser (diode laser) for dermatological applications (e.g., hair removal, treatment of dermal lesions). This device is connected to a control unit which supplies power to the handpiece and allows control of the treatment. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817495023007	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K230990	000