Geon (S2) Nasal Aspirator

The Geon (S2) Nasal Aspirator is a hand-held, non-invasive, battery-powered electronic device designed to remove nasal secretions and mucus from children ages 2-12 years old. It is intended for over-the-counter use in the home environment.

The device uses a 3V DC motor to generate negative pressure in a suction system, with a portable design and DC-powered operation. The main design difference from the predicate is the shape of the suction tip, which does not impact safety or effectiveness. Both devices share the same motor type, contact materials, vacuum pressure range (54-66 kPa), noise level (55-60 dB), storage container size, and operating principles.

IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11 for basic safety and essential performance, and electromagnetic compatibility. Verification testing included suction vacuum and noise measurements with specified tolerances.

The subject device is substantially equivalent because it has identical indications for use, motor type, applied-part type, contact materials, and operational principle as the predicate K220126 (Geonic Nasal Aspirator). The suction vacuum (54-66 kPa) and noise levels (55-60 dB) meet the same specifications. Although the suction tip shape differs, this design variation does not raise different questions regarding safety or effectiveness, as demonstrated by bench testing showing the device meets all manufacturer specifications and biocompatibility requirements.