Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043867

FEI Number

3001126113

Entity Name

INNOVATIVE EXCIMER SOLUTIONS, INC.

City/State/Country

Toronto Ontario, CA

Establishment Address

136 Sparks Avenue, Toronto Ontario M2H 2S4, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INNOVATIVE EXCIMER SOLUTIONS, INC. (Owner Number: 9004212)

Owner / Operator Contact Address

136 Sparks Avenue, Toronto, ON,, Toronto, CA-ON M2H 2S4, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K962989

PMA Number

N/A

All Registered Proprietary Names

Amoils Epithelial Scrubber

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOG	Burr, Corneal, Battery-Powered	Ophthalmic	Class 1	886.4070	2007-11-15

Official Correspondent

Mary Anne Bembridge

US Agent Details

Rich Wynkoop Business: Sunbreak Investments, LLC dba Vision28 Email: rich@vision28.com Phone: (541) 6049654

Related Public Records

Same Entity

INNOVATIVE EXCIMER SOLUTIONS, INC.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043867. Last updated year: 2026. Please use registration number 8043867 when referencing this establishment in official correspondence.