TOKYO, December 22, 2021 — Casio Computer Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has cleared the DZ-D100 DERMOCAMERA™ and the DZ-S50 scope for skin observation as medical devices. The DZ-D100 and DZ-S50 will be available in the U.S. on Casio America’s e-commerce site by March 2022.
Casio began providing the DZ-D100 in Japan in May 2019. The DZ-D100 was developed in collaboration with dermatology professional and delivers both standard sized and close-up shots of an affected area with a single unit, and can be used with the D’z IMAGE Viewer, a free downloadable software to manage the captured images. Casio then, in March 2020, released the DZ-S50 scope, which makes skin observation even easier. Medical professionals who have introduced these devices in their practice have provided positive feedback, commenting that these Casio products make it simple to take both ordinary or standard sized and close-up shots without switching lenses and they state it is easy to make observations since polarized, non-polarized, and UV* photos can be captured at the same angle of view with a single click of the shutter button. Casio has been rolling out these innovative medical devices aggressively in markets outside Japan, starting with the launch of sales in Australia and New Zealand in February 2021, where there are high rates of skin disease among the population.
- A 405 nm safelight wavelength is used.
The marketing of certain medical devices in the U.S. requires FDA clearance. The DZ-D100 and DZ-S50 have received FDA Class I clearance. Class I medical devices are devices with low or moderate risk to patient health and safety.
Casio will continue expanding and developing its medical device business both in and outside Japan, seeking to contribute to medical treatment around the world.