Myah

FDA 510(k) K211868 · Visia Imaging S.R.L.

Substantially Equivalent

510(k) numberK211868

Submission

Device name
Myah
Applicant
Visia Imaging S.R.L.
San Giovanni Valdarno, IT
Received
June 16, 2021
Decision date
March 1, 2022
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

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K223700Boss™MXK · Traditional Intelon Optics, Inc.08/16/2024SE
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K152311Pentacam AXLMXK · Traditional Oculus Optikgerate GmbH01/20/2016SE
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More from Santec Corporation

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K222933MyahMXK · Traditional 06/29/2023SE
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Questions and answers

When was Myah cleared by the FDA?

Myah (K211868) received a 510(k) decision of Substantially Equivalent on March 1, 2022, 258 days after the submission was received.

What is the product code of K211868?

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