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Data / Medical devices / United States / Pro-Optics LLC

Pro-Optics LLC: FDA-registered device maker in Palatine, IL, United States, 1 510(k) clearance

Pro-Optics LLC is registered with the FDA (registration 1419844) in Palatine, IL, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 9, 1988. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
1419844
Address
317 N Woodwork Ln, Palatine, IL, United States, 60067
Owner or operator
PRO-OPTICS LLC (1419844)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
December 1, 1983
Registered through
2026
Brand names listed
Ear Shop, Pro Moisture Chamber, Pro Shields, Pro-Moisture Chamber, Pro-Optics Eye/Ear Dropper, Pro-Shields, Tight Top Contact Lens Case, Tight-Top Contact Lens Case

Devices it lists

DeviceProduct codeClassRoleSource
Case, Contact LensLRX2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dropper, EntKCM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Protector, Hearing (Insert)EWDUContract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Manufactureraccessdata.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
February 9, 1988K875197OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASELRXSubstantially EquivalentPro-Optics, Inc.accessdata.fda.gov

Compare with other makers

Updated February 9, 1988. 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.