FDA.reportPublic FDA data

KOWA SL-19

Primary DI
04987646810223
Brand
KOWA SL-19
Company
KOWA COMPANY,LTD.
Model
SL191BK/W
Device 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.
Published
2023-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJOBiomicroscope, Slit-Lamp, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222372000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222372000Kowa SL-19Kowa Company , Ltd.2022-11-21HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987646810223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987646810223049876468102234987646810223

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic examination slit lampAn electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye by viewing through the pupil; it is not dedicated to surgical procedures. It projects a narrow slit of light into the eye and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular structures. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth197Millimeter
Height238Millimeter
Weight620Gram
Width107Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Regulatory Flags#

DUNS number
692281073
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987646807575KOWA nonmyd 8K9L61K2016-09-16
04987646810476KOWA SL-19SL192BK/W2024-10-08
04987646810032KOWA SL-19SL191K/W2022-12-07
04987646810049KOWA SL-19SL191K/A2022-12-07
04987646810056KOWA SL-19SL191K/G2022-12-07
04987646810063KOWA SL-19SL191K/P2022-12-07
04987646810070KOWA SL-19SL191K/B2022-12-07
04987646804031KOWA SL-15SL150K2016-09-16
04987646806905KOWA SL-17SL170K/W2016-09-16
04987646806912KOWA SL-17SL170K/A2016-09-16
04987646806929KOWA SL-17SL170K/G2016-09-16
04987646806936KOWA SL-17SL170K/P2016-09-16
04987646809128KOWA nonmyd AFK9L64K2020-01-15
04987646807728KOWA DR-1αDE2K2019-06-10
04987646808923KOWA VK-2sVK28K2019-06-10
04987646808930KOWA VK-2sVK28UE2019-06-10
04987646808947KOWA VK-2sVK28U2E2019-06-10
04987646805113KOWA AP-7000FT10K2019-01-08
04987646800583KOWA GENESIS-DfK9L51BK2016-09-16
04987646800606KOWA nonmyd a-DIIIK9L58K2018-02-23

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