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My DashboardInspection TrackerWarning LettersBlephEx, LLC

All Warning Letters

BlephEx, LLC

Warning LetterOpen

Recipient Name James M. Rynerson, M.D., BlephEx, LLC, 330 Franklin Road Suite 135A, Box 117 Brentwood , TN 37027-5252 United States, (b)(6)Issued Jun 3, 2026Center for Devices and Radiological Health

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

Violations23

Issue DateJun 3, 2026

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: BlephEx, LLC
Location: Recipient Name James M. Rynerson, M.D., BlephEx, LLC, 330 Franklin Road Suite 135A, Box 117 Brentwood , TN 37027-5252 United States, (b)(6)
FEI Number: N/A
Country: United States
Issue Date: June 03, 2026
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Subject

Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)

BlephEx, LLC FDA Warning Letter, June 3, 2026