Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034992373

FEI Number

3034992373

Entity Name

PLU OPHTHALMIC Corp

City/State/Country

Coral Gables, FL, US

Establishment Address

1 Alhambra Plz. Ste Ph, Coral Gables, FL 33134, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

PLU Ophthalmic (Owner Number: 10092298)

Owner / Operator Contact Address

1 Alhambra Plz. Ste PH, Coral Gables, FL 33134, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AquaLumen

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-12-20

Official Correspondent

Carlos Urrea

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PLU Ophthalmic

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
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.

Similar Registrations

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3031572059	TissueGUARD	Dresden Saxony, DE
3008754084	Belle Healthcare Technology Co., Ltd.	Suzhou Jiangsu, CN
3008719017	SUMMIT MEDICAL LLC	Saint Paul, MN, US
3012494290	SANICURE BV	SCHIPHOL Noord-Holland, NL
9611502	CARL TEUFEL GMBH & CO. KG	LIPTINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034992373. Last updated year: 2026. Please use registration number 3034992373 when referencing this establishment in official correspondence.