Myah

FDA UDI

Class II (US FDA UDI)

by Visia Imaging Srl

Identity

Trade Name: MYAH FDA UDI
Generic Name: Corneal topography system FDA UDI
Model / Reference: MYAH FDA UDI

Identifiers

Catalog Number: 42-0000983US FDA UDI
Primary DI / UDI-DI: 08034028770487 FDA UDI
510(k) Number: K222933 FDA UDI
FDA Product Code: MXK FDA UDI
HKI FDA UDI
GMDN Term: Corneal topography system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1850 FDA UDI
886.1120 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Corneal topography system

Myah by Visia Imaging Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Corneal topography system.

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WAVELIGHT ALLEGRO TOPOLYZER — Alcon Laboratories, Inc. · Class III
WAVE ANALYZER MEDICA 800 — ESSILOR INTERNATIONAL · Class II
Topographic Modeling System — Tomey Corporation · Class I
CASSINI — Cassini Technologies B.V. · Class I
WAVE ANALYZER MEDICA 700 PLUS — ESSILOR INTERNATIONAL · Class II

Cleared under the same submission

K222933 also covers:

ESSILOR — VISIA IMAGING SRL

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Visia Imaging Srl

Sources (1)

FDA UDI 3cba00ab-c01c-40f5-9cfc-fc663f75c8ac 34 fields · synced May 31, 2026