FDA-Device2013-11-27Class II
Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040
Candela Corporation
Hazard
Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.
Sold states
Worldwide distribution: US (nationwide) and Internationally to: Azerbaijan, Bulgaria, Chile, Czech Republic, Greece, Israel, Kuwait, Qatar, Saudi Arabia, Serbia, Turkey, and the United Arab Emirates and to Subsidiaries in Australia, France, Germany, Italy, Japan, Portugal, Spain, and the United Kingdom.
Affected count
1258 units
Manufactured in
530 Boston Post Rd, Wayland, MA, United States
Products
Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0348-2014Don't want to check this manually?
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