Vbeam Prima Pro DCD Handpiece 7123-00-0836

GUDID 00817495025247

ASSY, DCD HP, DELIVERY SYSTEM, VBEAM PRIMA PRO

Candela Corporation

Dermatological laser beam producing handpiece

• Primary Device ID: 00817495025247
• NIH Device Record Key: 6d782d2c-7016-4f04-98f1-73983e9019e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vbeam Prima Pro DCD Handpiece
• Version Model Number: 7123-00-0836
• Catalog Number: 7123-00-0836
• Company DUNS: 053468385
• Company Name: Candela Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495025247 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230990

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-23
• Device Publish Date: 2025-01-15

Devices Manufactured by Candela Corporation

• 00817495024059 - Vbeam Prima Pro Laser System: 2025-01-23 Vbeam Prima Pro Laser System Nd: YAG Configuration 1064, 595, DCD
• 00817495025247 - Vbeam Prima Pro DCD Handpiece: 2025-01-23ASSY, DCD HP, DELIVERY SYSTEM, VBEAM PRIMA PRO
• 00817495025247 - Vbeam Prima Pro DCD Handpiece: 2025-01-23 ASSY, DCD HP, DELIVERY SYSTEM, VBEAM PRIMA PRO
• 00817495024677 - PicoWay Laser System: 2024-10-21 PicoWay Laser System
• 00817495023540 - PicoWay Laser System: 2024-10-14 Picoway Laser System
• 00817495023663 - PicoWay Laser System: 2024-10-14 Picoway Laser System
• 00817495023588 - PicoWay Laser System: 2024-10-08 Picoway Laser System
• 00817495024639 - GYAG Pro U Laser System: 2024-10-02 GYAG Pro U Laser System
• 00817495024646 - Glase Pro U Laser System: 2024-10-02 Glase Pro U Laser System