FDA-Device2017-08-30Class II
VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
Solta Medical Inc
Hazard
Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.
Sold states
US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.
Affected count
4 units
Manufactured in
11720 N Creek Pkwy N Ste 100, Bothell, WA, United States
Products
VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3047-2017Don't want to check this manually?
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