FDA clears text

SafKan Health’s Automated Ear Cleaning Device Cleared

November 16, 2020

The FDA has granted SafKan Health 510(k) marketing clearance for its OtoSet ear-cleaning system, a device used by clinicians to remove impacted earwax.

The wearable device uses irrigation and microsuction technology to quickly remove the wax and features single-use disposable ear tips and disposable waste containers.

The company said that it is developing a consumer version of the device that can be used in the home to prevent excessive earwax buildup.

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