FDA.reportPublic FDA data

Microclear

Primary DI
06970990160074
Brand
Microclear
Company
Suzhou Microclear Medical Instruments Co., Ltd.
Model
HSL-01
Published
2021-01-27
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
06970990160074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970990160074069709901600746970990160074

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
548374439
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970990160029MicroclearHSL2021-01-27
06970990160081MicroclearHSL-022021-01-27
06970990160098MicroclearHSL-032021-01-27
06970990160012MicroclearHFC2021-01-27
06970990160043MicroclearFC-012021-01-27
06970990160050MicroclearFC-022021-01-27
06970990160067MicroclearFC-032021-01-27
06970990160104MicroclearVS2021-01-27
06970990160111MicroclearVS-Pro2021-01-27
06970990160128MicroclearVS-Plus2021-01-27
06970990160135MicroclearVS-T2021-01-27
06970990160142MicroclearVS-T Pro2021-01-27
06970990160159MicroclearVS-T Plus2021-01-27

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
00860010833209ILLUMINIXIlluminix Industries LLCPUE2024-01-23
00860010833247ILLUMINIXIlluminix Industries LLCPUE2024-01-23
00860010833261ILLUMINIXIlluminix Industries LLCPUE2024-01-23
08908006463497LABOMED SLx 40- 3 Step Slit lamp -HL (Halogen)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463503LABOMED SLx 45- 3 Step Slit lamp -HL(Halogen)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463510LABOMED SLx 40- 3 Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463527LABOMED SLx 45- 3 Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463534LABOMED eVO300 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463541LABOMED eVO400 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463558LABOMED eVO300 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463565LABOMED eVO400 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463572LABOMED eVO350 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463589LABOMED eVO450 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463596LABOMED eVO350 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463602LABOMED eVO450 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
06972039971405MOPTIMShenzhen CERTAINN Technology Co., Ltd.PUE2022-12-08
07640132985610Imaging SetHaag-Streit AGPUE2022-11-22
07640132986549HeadrestHaag-Streit AGPUE2022-11-22
07640132986556HeadrestHaag-Streit AGPUE2022-11-22
07640132986563HeadrestHaag-Streit AGPUE2022-11-22
07640132986570HeadrestHaag-Streit AGPUE2022-11-22