VBEAM Prima without Contact Cooling

GUDID 08174950202950

Pulsed Laser

CANDELA CORPORATION

Dermatological dye laser system

• Primary Device ID: 08174950202950
• NIH Device Record Key: 5580c25f-fd2a-4f8d-8b99-3936467f9cf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VBEAM Prima without Contact Cooling
• Version Model Number: 9914-00-9084
• 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

Customer Support Contacts

• Phone: 800-733-8550
• Email: customer.service@candelamedical.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08174950202950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183452

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: 2019-12-20
• Device Publish Date: 2019-12-12

On-Brand Devices [VBEAM Prima without Contact Cooling]

• 08174950202950: Pulsed Laser
• 00817495022956: Pulsed Laser