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BlephEx, LLC Warning Letter Details

Warning Letter

BlephEx, LLC

Recipient Name James M. Rynerson, M.D., BlephEx, LLC, 330 Franklin Road Suite 135A, Box 117 Brentwood , TN 37027-5252 United States, (b)(6)

Issue DateJune 03, 2026

FEI NumberN/A

Violations23

CountryUnited States

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