FDA-Device2023-11-29Class II
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
Convergent Dental
Hazard
It has been found that potential unintended laser activation can occur without foot pedal depression.
Sold states
Worldwide - US Nationwide distribution in the states of AK, AL, CA, CT, FL, KY, ME, MI, MO, MT, NC, OH, OR, PA, TN, TX, UT, VA, WA, WI and the country of Canada.
Affected count
39 units
Manufactured in
140 Kendrick St Bldg C3, N/A, Needham, MA, United States
Products
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0324-2024Don't want to check this manually?
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