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66 Vision Tech Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 3 510(k) clearances

66 Vision Tech Co., Ltd. is registered with the FDA (registration 3003553186) in Suzhou Jiangsu, China. It lists 24 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 9, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3003553186
Address
Building 2, No.9 Jinfeng Road, Suzhou Jiangsu, China, 215005
Owner or operator
SUZHOU 66 VISION TECH CO., LTD. (9055087)
Roles
Exporter to the US, Foreign private label distributor, Manufacturer
First device listed
June 28, 2002
Registered through
2026
Brand names listed
66 VISION TECH CANNULA, 66 VISION TECH LENS, 66 VISION TECH LENS(14D,20D,28D,40D,78D,90D), 66 VISION TECH MICROSCOPE, 66 VISION TECH OPHTHA, 66 VISION TECH OPHTHALMIC FORCEPS, 66 VISION TECH OPHTHALMIC HOOK, 66 VISION TECH OPHTHALMIC KNIFE and more

Devices it lists

DeviceProduct codeClassRoleSource
Biomicroscope, Slit-Lamp, Ac-PoweredHJO2Manufactureraccessdata.fda.gov
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl AcetalMXY1Exporter to the US, Manufactureraccessdata.fda.gov
ExophthalmometerHLS1Manufactureraccessdata.fda.gov
Forceps, OphthalmicHNR1Exporter to the US, Manufactureraccessdata.fda.gov
Hook, OphthalmicHNQ1Exporter to the US, Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Exporter to the US, Manufactureraccessdata.fda.gov
Instrument, Measuring, Lens, Ac-PoweredHLM1Exporter to the US, Manufactureraccessdata.fda.gov
Instrument, Measuring, StereopsisHLC1Exporter to the US, Manufactureraccessdata.fda.gov
Knife, OphthalmicHNN1Exporter to the US, Manufactureraccessdata.fda.gov
Lens, Condensing, DiagnosticHJL1Foreign private label distributor, Manufactureraccessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, OphthalmicHRM1Exporter to the US, Manufactureraccessdata.fda.gov
Monitor, Eye MovementHLL2Manufactureraccessdata.fda.gov
Ophthalmoscope, Battery-PoweredHLJ2Manufactureraccessdata.fda.gov
Projector, OphthalmicHOS1Exporter to the US, Manufactureraccessdata.fda.gov
Pupillometer, ManualHLH1Exporter to the US, Manufactureraccessdata.fda.gov
Retinoscope, Battery-PoweredHKM1Manufactureraccessdata.fda.gov
Ring, Ophthalmic (Flieringa)HNH1Exporter to the US, Manufactureraccessdata.fda.gov
Rongeur, Lachrymal SacHNG1Exporter to the US, Manufactureraccessdata.fda.gov
Scissors, OphthalmicHNF1Exporter to the US, Manufactureraccessdata.fda.gov
Spatula, OphthalmicHND1Exporter to the US, Manufactureraccessdata.fda.gov
Specula, OphthalmicHNC1Exporter to the US, Manufactureraccessdata.fda.gov
Spoon, OphthalmicHNB1Exporter to the US, Manufactureraccessdata.fda.gov
Spud, OphthalmicHNA1Exporter to the US, Manufactureraccessdata.fda.gov
Table, Instrument, Manual, OphthalmicHRK1Exporter to the US, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 9, 2014K131711YZ3 PORTABLE SLIT LAMPHJOSubstantially EquivalentSuzhou 66 Vision Tech Co., Ltd.accessdata.fda.gov
November 7, 2006K05259966 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25AHLJSubstantially EquivalentSuzhou 66 Vision Tech Co., Ltd.accessdata.fda.gov
December 4, 2003K033190VISION-TECH YZ SLIT LAMP, MODEL 66HJOSubstantially EquivalentSuzhou 66 Vision-Tech Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated May 9, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.