GentleMax Pro

GUDID 00817495020273

Pulsed Laser

Candela Corporation

Dermatological solid-state laser system

• Primary Device ID: 00817495020273
• NIH Device Record Key: 81ac6e6f-5909-4ecf-a3d7-60d15388f1fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GentleMax Pro
• Version Model Number: 9914-00-9335
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495020273 [Primary]
GS1	08174950200277 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140122

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: 6
• Public Version Date: 2022-10-12
• Device Publish Date: 2016-09-23

On-Brand Devices [GentleMax Pro]

• 08174950200970: Pulsed Laser
• 08174950200963: Pulsed Laser
• 08174950200956: Pulsed Laser
• 08174950200277: Pulsed Laser
• 08174950200017: Pulsed Laser
• 00817495020013: Pulsed Laser
• 00817495020976: Pulsed Laser
• 00817495020969: Pulsed Laser
• 00817495020952: Pulsed Laser
• 00817495020273: Pulsed Laser