FDA.reportPublic FDA data

KOWA FM-600

Primary DI
04987646804024
Brand
KOWA FM-600
Company
KOWA COMPANY,LTD.
Model
LSS50BK
Device description
KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye.
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MYCOphthalmoscope,Laser,Scanning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYCOphthalmoscope, Laser, ScanningOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091039000KOWA, FM-600, MODEL LSS50Kowa Co. , Ltd.2009-08-07MYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987646804024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987646804024049876468040244987646804024

GMDN Terms#

Term, Definition table
TermDefinition
Aqueous flare/cell measuring systemAn assembly of devices designed to measure aqueous flare (i.e., protein concentration) and the number of cells in the aqueous humour. It typically consists of light sources (e.g., lasers), a slit-lamp microscope, photo-multipliers, and dedicated software. The system measures the light scattered from the protein and cells in the aqueous humour using a photo-multiplier and analyse the results typically using a personal computer; it is mainly used to assess anterior chamber inflammation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth457Millimeter
Height458Millimeter
Weight18Kilogram
Width274Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

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
04987646810223KOWA SL-19SL191BK/W2023-01-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053677040123EIDONCENTERVUE SPAMYC2026-04-29
08053677040130MAIACENTERVUE SPAMYC2026-04-29
G744OCUB100OcuMet BeaconOcuSciences, Inc.MYC2025-06-25
04059237000235SPECTRALISHeidelberg Engineering GmbHMYC2025-03-24
04059237000723SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237000792SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237001027SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237001034SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04987669101568Scanning Laser OphthalmoscopeNIDEK CO.,LTD.MYC2023-06-12
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.MYC2023-06-12
04059237000884SPECTRALISHeidelberg Engineering GmbHMYC2022-10-26
04059237000891SPECTRALISHeidelberg Engineering GmbHMYC2022-10-26
04059237000815SPECTRALISHeidelberg Engineering GmbHMYC2022-02-02
04059237000839SPECTRALISHeidelberg Engineering GmbHMYC2022-02-02
00849233012066Busse Hospital DisposablesROBERT BUSSE & CO., INC.MYC2020-04-08
10849233012063Busse Hospital DisposablesROBERT BUSSE & CO., INC.MYC2020-04-08
04059237000464SPECTRALISHeidelberg Engineering GmbHMYC2020-01-21
04059237000488SPECTRALISHeidelberg Engineering GmbHMYC2020-01-21
08053677040116DRSplusCENTERVUE SPAMYC2019-12-09
04059237000716SPECTRALISHeidelberg Engineering GmbHMYC2019-10-29
05057056107509OCT Ophthalmoscope OPTOS PUBLIC LIMITED COMPANYMYC2019-10-29
04059237000570SPECTRALISHeidelberg Engineering GmbHMYC2019-04-23
04059237000594SPECTRALISHeidelberg Engineering GmbHMYC2019-04-23
04059237000211SPECTRALISHeidelberg Engineering GmbHMYC2019-01-03
04059237000501SPECTRALISHeidelberg Engineering GmbHMYC2019-01-03
04059237000525SPECTRALISHeidelberg Engineering GmbHMYC2019-01-03
04059237000549SPECTRALISHeidelberg Engineering GmbHMYC2019-01-03
08053677040093EIDONCENTERVUE SPAMYC2018-07-23
04059237000341SPECTRALISHeidelberg Engineering GmbHMYC2018-07-11
04059237000358SPECTRALISHeidelberg Engineering GmbHMYC2018-07-11