FDA.reportPublic FDA data

Ophthalmic Slit Lamp Microscope

Primary DI
06973211070473
Brand
Ophthalmic Slit Lamp Microscope
Company
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
Model
LS-8
Device description
It is an AC-powered slit lamp Bio-microscope 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 affects the structural properties of the anterior eye segment
Published
2020-07-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PUEBiomicroscope, Slit-Lamp, Ac-Powered, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUEBiomicroscope, Slit-Lamp, Ac-Powered, ExemptOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973211070473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973211070473069732110704736973211070473

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, examinationA mains electricity (AC-powered), ophthalmic, binocular microscope designed to examine the interior anatomy of the eye (anterior and posterior surfaces) by viewing through the iris. It produces a narrow slit of powerful light which is projected into the eye, and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular surfaces. 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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545824560
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973211070619Fundus Camera SK-650B2025-08-18
06973211070930Ophthalmic Slit Lamp MicroscopeLS-6C2025-08-18
06973211070947Ophthalmic Slit Lamp MicroscopeLS-7C2025-08-18
06973211070954Ophthalmic Slit Lamp MicroscopeLS-7CS2025-08-18
06973211070961Ophthalmic Slit Lamp MicroscopeLS-7CE2025-08-18
06973211070978Ophthalmic Slit Lamp MicroscopeLS-8A2025-08-18
06973211070985Ophthalmic Slit Lamp MicroscopeLS-9CS2025-08-18
06973211071500Fundus CameraSK-680B2025-08-18
06973211071517Fundus CameraSK-680C2025-08-18
06973211071623Corneal Topographer SK-7000A2025-08-18
06973211071630Corneal Topographer SK-7000B2025-08-18
06973211071869Kerato refractometerSK-6800A2025-08-18
06973211071876Kerato refractometerSK-6800B2025-08-18
06973211070633Ophthalmic Ultrasound Examination InstrumentSK-3000A2023-01-17
06973211070640Ophthalmic Ultrasound Examination InstrumentSK-2000AP2023-01-17
06973211070701Ophthalmic Ultrasound Examination InstrumentSK-3000B2023-01-17
06973211070718Ophthalmic Ultrasound Examination InstrumentSK-3000C2023-01-17
06973211070749Ophthalmic Ultrasound Examination InstrumentSK-2000A2023-01-17
06973211070756Ophthalmic Ultrasound Examination InstrumentSK-2000P2023-01-17
06973211070916Sunkingdom RetinometerSK-6500A2023-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975449020022SYLChongQing SS Medical Equipments Co., LtdPUE2026-05-14
06975449020039SYLChongQing SS Medical Equipments Co., LtdPUE2026-05-14
06975449020046SYLChongQing SS Medical Equipments Co., LtdPUE2026-05-14
06973211070930Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070947Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070954Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070961Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070978Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070985Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
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