Specular Microscope

FDA UDI

Class II (US FDA UDI)

by Tomey Corporation

Identity

Trade Name: Specular Microscope FDA UDI
Generic Name: Ophthalmic examination slit lamp FDA UDI
Model / Reference: EM-4000 FDA UDI

Identifiers

Primary DI / UDI-DI: 04582273612822 FDA UDI
510(k) Number: K171313 FDA UDI
FDA Product Code: NQE 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

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

Yes

FDA UDI

Category: Ophthalmic examination slit lamp

Specular Microscope by Tomey Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic examination slit lamp.

Mediworks — SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD. · Class II
ILLUMINIX — Illuminix Industries LLC · Class II
Visionix — RIGHT MFG. CO., LTD. · Class II
Slit Lamp BQ 900 — Haag-Streit AG · Class II
S4 OPTIK — COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL · Class II
SLH 5XC 6V TBL USA — KEELER LIMITED · Class II
SLH 5XC 6V TBL — KEELER LIMITED · Class II
Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class II

Cleared under the same submission

K171313 also covers:

SPECULAR MICROSCOPE — Tomey Corporation

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Tomey Corporation

Sources (1)

FDA UDI 4c988a90-8c65-4d22-8717-e7f215f57750 34 fields · synced May 30, 2026