Kowa Sl-17

FDA UDI

Class II (US FDA UDI)

by Kowa Co. , Ltd.

Identity

Trade Name: KOWA SL-17 FDA UDI
Generic Name: Ophthalmic examination slit lamp FDA UDI
Device Name: KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment. FDA UDI
Model / Reference: SL170K/W FDA UDI
Description: KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987646806905 FDA UDI
510(k) Number: K133755 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

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

Dimensions & Sizes

Size: Width — 220 Millimeter FDA UDI
Weight — 745 Gram FDA UDI
Height — 220 Millimeter FDA UDI
Depth — 95 Millimeter FDA UDI

Category: Ophthalmic examination slit lamp

KOWA SL-17 is a comprehensive, binocular ophthalmic microscope designed to examine the interior anatomy of the eye. Using a travelling microscope, it projects a narrow slit of light into the eye and detects resulting light reflections to enable observation of internal ocular structures.

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Cleared under the same submission

K133755 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: Kowa Co. , Ltd.

Sources (1)

FDA UDI 374c6ce1-d64d-43f4-86a2-d0d34215a030 36 fields · synced Jun 19, 2026