FDA-Device2016-11-02Class II
FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
Lumenis Limited
Hazard
The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.
Sold states
Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.
Affected count
69 units
Manufactured in
13 Hayetzira St.,Yokneam Ind. Park, Yokneam, Israel
Products
FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0301-2017Don't want to check this manually?
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