Myah

FDA 510(k) K222933 · Visia Imaging S.R.L.

Substantially Equivalent

510(k) numberK222933

Submission

Device name
Myah
Applicant
Visia Imaging S.R.L.
San Giovanni Valdarno, IT
Received
September 26, 2022
Decision date
June 29, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MXK – Device, Analysis, Anterior Segment
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1850
Specialty
Ophthalmic

Other 510(k)s with product code MXK

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K223700Boss™MXK · Traditional Intelon Optics, Inc.08/16/2024SE
K211868MyahMXK · Traditional Visia Imaging S.R.L.03/01/2022SE
K202989Myopia MasterMXK · Traditional Oculus Optikgeräte GmbH07/14/2021SE
K201724Pentacam AXL WaveMXK · Traditional Oculus Optikgerate GmbH10/21/2020SE
K182659Galilei G6 Lens ProfessionalMXK · Traditional Sis Ag, Surgical Instrument Systems07/25/2019SE
K191051ArgosMXK · Traditional Santec Corporation05/16/2019SE
K152311Pentacam AXLMXK · Traditional Oculus Optikgerate GmbH01/20/2016SE
K150754ArgosMXK · Traditional Santec Corporation10/02/2015SE

More from Santec Corporation

510(k)DeviceDecision
K211868MyahMXK · Traditional 03/01/2022SE
K160327Aladdin HW3.0HJO · Traditional 10/05/2016SE
K131567AladdinHJO · Traditional 06/05/2014SE

Questions and answers

When was Myah cleared by the FDA?

Myah (K222933) received a 510(k) decision of Substantially Equivalent on June 29, 2023, 276 days after the submission was received.

What is the product code of K222933?

The FDA product code is MXK – Device, Analysis, Anterior Segment, a Class II (moderate risk) device regulated under 21 CFR 886.1850.