FDA-Device2022-07-20Class II
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Spectranetics Corporation
Hazard
The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared.
Sold states
US: AR AZ CA CO CT FL GA HI IA IL IN KS LA MA MD ME MI MN MO NC NJ NY OK PA TN TX VA OUS: Saudi Arabia, Denmark, France, Greece, India, Italy, Netherlands, Serbia, Spain, Sweden, United Kingdom
Affected count
105 units
Manufactured in
9965 Federal Dr, Colorado Springs, CO, United States
Products
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1351-2022Don't want to check this manually?
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