Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023125126

FEI Number

3023125126

Entity Name

Vista Ophthalmics

City/State/Country

Houston, TX, US

Establishment Address

1237 Campbell Rd, Houston, TX 77055, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Vista Ophthalmics, LLC (Owner Number: 10085476)

Owner / Operator Contact Address

1237 Campbell Road, Houston, TX 77055, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220030

PMA Number

N/A

All Registered Proprietary Names

Vista IS Vista 1-Step

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-11-19
MLZ	Vitrectomy, Instrument Cutter	Ophthalmic	Class 2	886.4150	2022-06-22

Official Correspondent

Don Knowles

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Vista Ophthalmics, 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
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.
Z-2096-2017	Abbott Medical Optics Inc. (AMO)	2	AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.
Z-0304-2026	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROBE 8065753179 UNITY 25+ HYPERVIT 30K VIT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-2108-2025	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A

Similar Registrations

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3034992373	PLU OPHTHALMIC Corp	Coral Gables, FL, US
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

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023125126. Last updated year: 2026. Please use registration number 3023125126 when referencing this establishment in official correspondence.