FDA-Device2013-10-30Class II
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Convergent Dental
Hazard
Specific error condition could lead to unintended laser emission during laser activation.
Sold states
US distribution including states of: MA, CT, NY.
Affected count
5
Manufactured in
2 Vision Dr, N/A, Natick, MA, United States
Products
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0050-2014Don't want to check this manually?
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