Volk Pictor Prestige retinal set

FDA UDI

Class II (US FDA UDI)

by Optomed Corp.

Identity

Trade Name: Volk Pictor Prestige retinal set FDA UDI
Generic Name: Multi-purpose digital medical camera FDA UDI
Device Name: Volk Pictor Prestige retinal set including Pictor Prestige camera and Pictor Prestige retina module. FDA UDI
Model / Reference: 60101813A FDA UDI
Description: Volk Pictor Prestige retinal set including Pictor Prestige camera and Pictor Prestige retina module. FDA UDI

Identifiers

Primary DI / UDI-DI: 06430046260887 FDA UDI
510(k) Number: K180378 FDA UDI
FDA Product Code: HKI FDA UDI
GMDN Term: Multi-purpose digital medical camera FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Yes

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: Multi-purpose digital medical camera

Volk Pictor Prestige retinal set by Optomed Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K180378 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: Optomed Corp.

Sources (1)

FDA UDI 995af045-3844-4eaf-a9e7-7f32ea2f9814 34 fields · synced May 30, 2026