FDA.reportPublic FDA data

MOPTIM

Primary DI
06972039971405
Brand
MOPTIM
Company
Shenzhen CERTAINN Technology Co., Ltd.
Model
SL-M6
Device description
The Slit Lamp comprises an illumination and a Binocular Microscope. The entire device can be moved in front of the eye using the instrument base. The illumination offers a range of setting possibilities for making the practically invisible areas of the eye visible. There is also a range of accessories available for the Slit Lamp to allow special diagnosis possibilities in addition to the general examinations. A camera may be attached to the slit lamp to take photographs of different parts of the eye.
Published
2022-12-08
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
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
06972039971405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972039971405069720399714056972039971405

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Regulatory Flags#

DUNS number
526992561
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972039971054MOPTIMC12025-08-15
06972039971085MOPTIMeasyCam2025-06-30
06972039971016MOPTIMR2X2025-06-23
06972039971023MOPTIMR3X2025-06-23
06972039971061MOPTIMOPM500D2025-06-23
06972039971078MOPTIMOPM500C2025-06-23
06972039971221MOPTIMOPM5002025-06-23
06972039971214MOPTIMeasyRef Pro2025-06-19
06972039971573MOPTIMeasyRef2023-02-03
06972039971542MOPTIMiRef2022-12-08
06972039971641MOPTIMDEA2022-12-08

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
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
07640132986600HeadrestHaag-Streit AGPUE2022-11-22