Lumenis FemTouch

The Lumenis FemTouch is a fractional CO2 delivery system for gynecology rather than a separate laser console. It attaches to a Lumenis CO2 laser, so the energy is the 10,600 nm CO2 wavelength produced by the host system. A February 2016 product note in OBG Management said FemTouch was designed for the AcuPulse MultiMode SuperPulse CO2 laser and that the beam is applied along the vaginal wall to ablate and coagulate the lining. FDA recall records place the FemTouch delivery system under K100415, the 2010 clearance for the AcuPulse 30/40 ST and AcuPulse 40WG CO2 laser systems.

FDA's device identifier database shows how the kit is built. FemTouch handpiece records were published in August 2016, along with a Plane Tip. A Standard Focus Tip and a Fine Focus Tip, both reusable and steam sterilized before each use, appear in October 2020, followed in December 2020 by sterile single-use Standard Focus and Fine Focus disposable tips. A FemTouch Adaptor kit is listed as well.

In September 2016 Lumenis sent customers an urgent field safety notice because the cleaning instructions in the FemTouch operator's manual might not work on a fully assembled device. The Class 2 recall covered all serial numbers. Customers received a disassembly tool kit and instructions for taking the device apart during pre-cleaning, and FDA lists the recall as terminated. Lumenis still shows FemTouch on its aesthetics product menu next to AcuPulse.

Because FemTouch is an accessory, a listing is usually either an AcuPulse console sold with the kit or the kit on its own. Say which, and give the console model and serial number if one is included. Buyers will want to see the disassembly tool from the 2016 field action, every reusable tip, and any sealed disposable tips with their expiration dates. For the console, expect questions about the CO2 laser's service history, the articulated arm and the handpiece optics.