Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023808060

FEI Number

3023808060

Entity Name

VIALASE INC.

City/State/Country

Aliso Viejo, CA, US

Establishment Address

95 Enterprise Ste 100, Aliso Viejo, CA 92656, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

ViaLase Inc. (Owner Number: 10095194)

Owner / Operator Contact Address

95 Enterprise, Suite 100, Aliso Viejo, CA 92656, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2026-02-04

Official Correspondent

Carlos Suarez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ViaLase Inc.

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
K170322	Abbott Medical Optics, Inc.	Catalys Precision Laser System	2017-05-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-1515-2015	Abbott Medical Optics, Inc.	2	OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023808060. Last updated year: 2026. Please use registration number 3023808060 when referencing this establishment in official correspondence.