GentleYAG

GUDID 08174950201083

Pulsed Laser

CANDELA CORPORATION

Dermatological solid-state laser system

• Primary Device ID: 08174950201083
• NIH Device Record Key: 2363edcf-ee7a-473c-841e-4122edac8709
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GentleYAG
• Version Model Number: 9914-08-0962
• 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

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	08174950201083 [Primary]

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: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-09-23

On-Brand Devices [GentleYAG ]

• 08174950202639: Pulsed Laser
• 08174950202622: Pulsed Laser
• 08174950201892: Pulsed Laser
• 08174950201885: Pulsed Laser
• 08174950201878: Pulsed Laser
• 08174950201120: Pulsed Laser
• 08174950201113: Pulsed Laser
• 08174950201106: Pulsed Laser
• 08174950201090: Pulsed Laser
• 08174950201083: Pulsed Laser
• 08174950201076: Pulsed Laser
• 08174950201069: Pulsed Laser
• 08174950201052: Pulsed Laser
• 08174950200833: Pulsed Laser
• 08174950200826: Pulsed Laser
• 08174950200819: Pulsed Laser
• 08174950200321: Pulsed Laser
• 00817495020839: Pulsed Laser
• 00817495020822: Pulsed Laser
• 00817495020327: Pulsed Laser
• 00817495021126: Pulsed Laser
• 00817495021119: Pulsed Laser
• 00817495021102: Pulsed Laser
• 00817495021096: Pulsed Laser
• 00817495021089: Pulsed Laser
• 00817495021072: Pulsed Laser
• 00817495021065: Pulsed Laser
• 00817495021058: Pulsed Laser
• 00817495022635: Pulsed Laser
• 00817495022628: Pulsed Laser
• 00817495020815: Pulsed Laser
• 00817495021898: Pulsed Laser
• 00817495021881: Pulsed Laser
• 00817495021874: Pulsed Laser