Visionix

FDA UDI

Class II (US FDA UDI)

by Right Mfg. Co., Ltd.

Identity

Trade Name: Visionix FDA UDI
Generic Name: Ophthalmic examination slit lamp FDA UDI
Device Name: DIGITAL PHOTO UNIT SET with Dicom FDA UDI
Model / Reference: MW50D FDA UDI
Description: DIGITAL PHOTO UNIT SET with Dicom FDA UDI

Identifiers

Catalog Number: VSN5700DB FDA UDI
Primary DI / UDI-DI: 04580606432024 FDA UDI
510(k) Number: K110129 FDA UDI
FDA Product Code: HJO FDA UDI
GMDN Term: Ophthalmic examination slit lamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1850 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

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

Yes

FDA UDI

Dimensions & Sizes

Size: Width — 350 Millimeter FDA UDI
Depth — 387 Millimeter FDA UDI
Height — 678.5 Millimeter FDA UDI
Weight — 14 Kilogram FDA UDI

Category: Ophthalmic examination slit lamp

Visionix by Right Mfg. Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K110129 also covers:

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: Right Mfg. Co., Ltd.

Sources (1)

FDA UDI 79cd71a7-5175-41db-85ec-77f87a1b2e80 37 fields · synced Jun 6, 2026