Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004497289

FEI Number

3004497289

Entity Name

OPHTHALMED LLC

City/State/Country

ROSWELL, GA, US

Establishment Address

1050 Northfield Ct Ste 280, ROSWELL, GA 30076, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OPHTHALMED LLC (Owner Number: 9051325)

Owner / Operator Contact Address

1050 NORTHFIELD COURT, SUITE 280, Roswell, GA 30076, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K050807

PMA Number

N/A

All Registered Proprietary Names

A4xx010 (20g laser/asp probe) A6xxx10 (20g laser/illum/asp probe) A92x013 (23g laser/asp probe) B62xx13 (23g laser/illum/asp probe) A5xxx0x (20g, 23g and 25g laser/illum probe)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2005-12-23

Official Correspondent

JAY MANSOUR

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OPHTHALMED 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
K834060	F. & F. Koenigkramer	RELIANCE OPHTHALMIC SLIT LAMP R-083	1984-02-04

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3007851054	Avedro, A Glaukos Company	Burlington, MA, US
2031962	STALLION MEDICAL, INC.	SAN DIEGO, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004497289. Last updated year: 2026. Please use registration number 3004497289 when referencing this establishment in official correspondence.