GentleLASE Pro-U

GUDID 00817495020938

Pulsed Laser

CANDELA CORPORATION

Dermatological solid-state laser system

• Primary Device ID: 00817495020938
• NIH Device Record Key: 06adc3b2-794c-4d5f-8235-587670908dbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GentleLASE Pro-U
• Version Model Number: 9914-15-9030
• 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

Operating and Storage Conditions

• 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	00817495020938 [Primary]
GS1	08174950200932 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140732

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: 5
• Public Version Date: 2020-06-12
• Device Publish Date: 2016-09-23

On-Brand Devices [GentleLASE Pro-U]

• 08174950200987: Pulsed Laser
• 08174950200949: Pulsed Laser
• 08174950200932: Pulsed Laser
• 08174950200925: Pulsed Laser
• 08174950200086: Pulsed Laser
• 00817495020082: Pulsed Laser
• 00817495020983: Pulsed Laser
• 00817495020945: Pulsed Laser
• 00817495020938: Pulsed Laser
• 00817495020921: Pulsed Laser