FDA.reportPublic FDA data

Ophthalmic Slit Lamp Microscope

Primary DI
06973211070947
Brand
Ophthalmic Slit Lamp Microscope
Company
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
Model
LS-7C
Published
2025-08-18
Public version status
New
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
06973211070947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973211070947069732110709476973211070947

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).

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
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
06973211070923Sunkingdom RetinometerSK-6500B2023-01-17

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
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
00860010833209ILLUMINIXIlluminix Industries LLCPUE2024-01-23
00860010833247ILLUMINIXIlluminix Industries LLCPUE2024-01-23
00860010833261ILLUMINIXIlluminix Industries LLCPUE2024-01-23
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