Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010351679

FEI Number

3010351679

Entity Name

BlephEx, LLC

City/State/Country

Brentwood, TN, US

Establishment Address

500 Wilson Pike Circle, SUITE # 103, Brentwood, TN 37027, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BlephEx, LLC (Owner Number: 10044025)

Owner / Operator Contact Address

1200 Talon Way, Franklin, TN 37069, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BlephEx BlephEx Relief LashCamIR Vibratory Expression Forceps (VEF) BlephEx Procedural Tips OptiVize

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PYU	Sponge, Eyelid Cleaning, Powered	General, Plastic Surgery	Class 1	878.4820	2017-09-12
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2021-09-24
PJZ	Camera, Ophthalmic, General-Use	Ophthalmic	Class 2	886.1120	2020-01-10
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-04-27
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2018-11-29
HPY	Unit, Electrolysis, Battery-Powered, Ophthalmic	Ophthalmic	Class 1	886.4250	2020-07-27

Official Correspondent

James Rynerson, MD

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BlephEx, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010351679. Last updated year: 2026. Please use registration number 3010351679 when referencing this establishment in official correspondence.