Vbeam Prima Pro Laser System 9914-00-9092

GUDID 00817495024059

Vbeam Prima Pro Laser System Nd: YAG Configuration 1064, 595, DCD

Candela Corporation

Dermatological dye laser system

• Primary Device ID: 00817495024059
• NIH Device Record Key: 005bf447-bfc1-43a0-b8cb-de52ee5727da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vbeam Prima Pro Laser System
• Version Model Number: 9914-00-9092
• Catalog Number: 9914-00-9092
• 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	00817495024059 [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

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• 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: 2025-01-23 ASSY, DCD HP, DELIVERY SYSTEM, VBEAM PRIMA PRO
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