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My DashboardInspection TrackerWarning LettersPro-Optics, LLC

All Warning Letters

Pro-Optics, LLC

Warning LetterOpen

Pro-Optics, LLC, 317 N Woodwork Ln Palatine , IL 60067-4932 United States, (b)(6), (b)(7)(C)Issued Oct 5, 2026Center for Devices and Radiological Health

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateOct 5, 2026

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Pro-Optics, LLC
Location: Pro-Optics, LLC, 317 N Woodwork Ln Palatine , IL 60067-4932 United States, (b)(6), (b)(7)(C)
FEI Number: N/A
Country: United States
Issue Date: October 05, 2026
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Subject

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

Pro-Optics, LLC FDA Warning Letter, October 5, 2026