Vbeam Aesthetica

GUDID 00817495021492

Pulsed Laser

CANDELA CORPORATION

Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system

• Primary Device ID: 00817495021492
• NIH Device Record Key: a4ac6d36-cd99-4483-bed4-4e2d8c41d072
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vbeam Aesthetica
• Version Model Number: 9914-00-0312
• 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: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com
• Phone: 800-735-2737
• Email: customerservice@syneron-candela.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495021492 [Primary]
GS1	08174950201496 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050673
• 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-06-29
• Device Publish Date: 2016-09-23

On-Brand Devices [Vbeam Aesthetica]

• 00817495021492: Pulsed Laser
• 00817495020624: Pulsed Laser
• 00817495020365: Pulsed Laser
• 00817495020358: Pulsed Laser