Kowa Sl-19

FDA UDI

Class II (US FDA UDI)

by Kowa Co. , Ltd.

Identity

Trade Name: KOWA SL-19 FDA UDI
Generic Name: Ophthalmic examination slit lamp FDA UDI
Device Name: KOWA SL-19 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: SL191BK/W FDA UDI
Description: KOWA SL-19 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: 04987646810223 FDA UDI
510(k) Number: K222372 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: Weight — 620 Gram FDA UDI
Width — 107 Millimeter FDA UDI
Depth — 197 Millimeter FDA UDI
Height — 238 Millimeter FDA UDI

Category: Ophthalmic examination slit lamp

Kowa Sl-19 by Kowa Co. , Ltd. — 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

K222372 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

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

Manufacturer

Manufacturer: Kowa Co. , Ltd.

Sources (1)

FDA UDI 27b6f6f3-5196-4664-a720-9ce8945ccb77 36 fields · synced May 30, 2026