Has BlephEx, LLC had other FDA enforcement actions?

This is the only FDA action Argus HQ has on file for BlephEx, LLC so far. Argus ingests new FDA enforcement records daily.

Which FDA office issued the warning letter to BlephEx, LLC?

Center for Devices and Radiological Health issued the warning letter to BlephEx, LLC.

What CFR citations does this warning letter reference?

The letter cites: FDA Warning Letter.

Is the FDA warning letter to BlephEx, LLC publicly available?

Yes. The full verbatim letter is published at fda.gov: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/blephex-llc-725861-06032026.

Warning Letter Record: BlephEx, LLC (June 3, 2026) — Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)

Key facts

Company	BlephEx, LLC
FDA office	Center for Devices and Radiological Health
Letter date	June 3, 2026
Subject / product	Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
CFR citations	FDA Warning Letter
Response due	15 working days from receipt (standard FDA warning-letter requirement)
Reference / source ID	blephex-llc-725861-06032026

In short: FDA issued a Warning Letter to BlephEx, LLC on 2026-06-03, citing: Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). The letter was issued by FDA’s Center for Devices and Radiological Health. A Warning Letter identifies violations FDA believes are significant enough to warrant prompt correction; it is not a final legal determination that a law was broken. This page presents FDA’s own letter language -- always confirm citation details against the original document before relying on it. FDA issues Warning Letters after an inspection or other review when it believes a firm has significantly violated FDA regulations; the letter itself is a notice, not a final adjudication.

What happens next

BlephEx, LLC is expected to respond to FDA in writing, typically within 15 working days of the letter date, describing the specific corrective and preventive actions taken or planned for each violation cited. FDA reviews that response and any follow-up evidence, and can conduct a re-inspection to confirm the corrections were actually made. If FDA judges the response inadequate, or the underlying conditions serious enough, further action can follow, including product seizure, injunction, import alert, or civil penalties; many Warning Letters are resolved through corrective action alone. This page reflects the Warning Letter as issued and will not reflect any subsequent correction unless FDA publishes a follow-up record. FDA issues Warning Letters after an inspection or other review when it believes a firm has significantly violated FDA regulations; the letter itself is a notice, not a final adjudication.

Violations explained

FDA Warning Letter — Violations FDA cited at BlephEx, LLC

WARNING LETTER BlephEx, LLC MARCS-CMS 725861 — June 03, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name James M. Rynerson, M.D. Recipient Title Owner & President BlephEx, LLC 330 Franklin Road Suite 135A, Box 117 Brentwood , TN 37027-5252 United States (b)(6) Issuing Office: Center for Devices and Radiological Health United States June 3, 2026 WARNING LETTER CMS #725861 Dear Dr. Rynerson: During an inspection of your firm located in Brentwood, TN from October 30, 2025, through November 19, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the BlephEx Powered Eyelid Cleaning Sponge, the OptiVize Ophthalmic Battery-Powered Electrolysis Unit, and the OptiVize Ophthalmic Forceps. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. Unapproved Device Violations Based on our review of the evidence collected during the inspection, your firm’s responses dated December 12, 2025, January 30, 2026, February 27, 2026, March 31, 2026, April 30, 2026, and May 29, 2026, and your firm’s website, www.blephex.com, we determined that the following products are adulterated and misbranded. Specifically: The BlephEx Powered Eyelid Cleaning Sponge is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The BlephEx Powered Eyelid Cleaning Sponge is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction this device into interstate commerce for commercial distribution, intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 878.4820 without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a). On July 7, 2017, your firm submitted a request to FDA for information regarding your “Eyelid Cleaning Product” under section 513(g) of the Act. In that request, your firm proposed, in part, that the Eyelid Cleaning Product be regulated under 21 CFR 878.4820 as a class I device exempt from 510(k) notification, specifying an indication for a “battery-operated [eyelid cleaning] device intended to provide power to operate a spinning micro-sponge that cleans the eyelids”. Your firm described the Eyelid Cleaning Product for “eyelid cleaning/hygiene, and not for the cure, treatment or mitigation of any disease or condition. The purpose of the eyelid cleaning product is to maintain hygiene as part of a healthy lifestyle that may help to reduce the risk of blepharitis and dry eye.” Further, your firm stated that the Eyelid Cleaning Product is not intended to be used as a treatment. On September 11, 2017, FDA responded to your firm. Based on the information provided, FDA believed that the Eyelid Cleaning Product falls within 21 CFR 878.4820, Surgical instrument motors and accessories/attachments (product code PYU) as a class I device exempt from premarket notification requirements of the Act, subject to the limitations under 21 CFR 878.9. The “Eyelid Cleaning Product” referenced in your firm’s July 7, 2017, correspondence has since been marketed as the BlephEx Powered Eyelid Cleaning Sponge. However, there is evidence that the BlephEx Powered Eyelid Cleaning Sponge is intended for uses that are different

BlephEx, LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to BlephEx, LLC: 1 warning letter, 0 recalls, 0 approval records, and 0 Form 483 inspection citations.

Full letter text

Read the rest of the full text

help to reduce the risk of blepharitis and dry eye.” Further, your firm stated that the Eyelid Cleaning Product is not intended to be used as a treatment. On September 11, 2017, FDA responded to your firm. Based on the information provided, FDA believed that the Eyelid Cleaning Product falls within 21 CFR 878.4820, Surgical instrument motors and accessories/attachments (product code PYU) as a class I device exempt from premarket notification requirements of the Act, subject to the limitations under 21 CFR 878.9. The “Eyelid Cleaning Product” referenced in your firm’s July 7, 2017, correspondence has since been marketed as the BlephEx Powered Eyelid Cleaning Sponge. However, there is evidence that the BlephEx Powered Eyelid Cleaning Sponge is intended for uses that are different

Frequently asked questions

Has BlephEx, LLC had other FDA enforcement actions?: This is the only FDA action Argus HQ has on file for BlephEx, LLC so far. Argus ingests new FDA enforcement records daily.
Which FDA office issued the warning letter to BlephEx, LLC?: Center for Devices and Radiological Health issued the warning letter to BlephEx, LLC.
What CFR citations does this warning letter reference?: The letter cites: FDA Warning Letter.
Is the FDA warning letter to BlephEx, LLC publicly available?: Yes. The full verbatim letter is published at fda.gov: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/blephex-llc-725861-06032026.

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Full FDA history for BlephEx, LLC

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Warning Letter Record: BlephEx, LLC (June 3, 2026) — Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). Digital Empire LLC. Retrieved from https://argushq.ai/warning-letter/blephex-725861-2026-06-03

MLA

"Warning Letter Record: BlephEx, LLC (June 3, 2026) — Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/warning-letter/blephex-725861-2026-06-03.

Chicago

Argus HQ Research. "Warning Letter Record: BlephEx, LLC (June 3, 2026) — Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/warning-letter/blephex-725861-2026-06-03.

BibTeX

@misc{argushq_argushq_ai_warning_letter_blephex_725861_2026_06_03_2026,
  title = {Warning Letter Record: BlephEx, LLC (June 3, 2026) — Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/warning-letter/blephex-725861-2026-06-03},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Warning Letters ↗