Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612327

FEI Number

3002807445

Entity Name

LABTICIAN OPHTHALMICS, INC.

City/State/Country

OAKVILLE Ontario, CA

Establishment Address

2140 WINSTON PARK DR., UNIT 6, OAKVILLE Ontario L6H 5V5, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LABTICIAN OPHTHALMICS, INC. (Owner Number: 8022288)

Owner / Operator Contact Address

2140 WINSTON PARK DR., UNIT 6, --, OAKVILLE, CA-ON L6H 5V5, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K983607

PMA Number

N/A

All Registered Proprietary Names

Labtician Retinal Implant LSO QUICKSET LABTICIAN LID LOAD ADHESIVE STRIPS LabVit Kit Labtician Lid Load Gold Eyelid Weight Implant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQJ	Implant, Absorbable, (Scleral Buckling Methods)	Ophthalmic	Class 2	886.3300	2007-11-20
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2004-10-14
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	1999-04-20
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2009-08-20
MML	Weights, Eyelid, External	Ophthalmic	Class 2	886.5700	2007-11-20

Official Correspondent

Phil Cuscuna

US Agent Details

Emily M. Digenis Business: Attorney at Law Email: emilydigenis@gmail.com Phone: (502) 5895544

Related Public Records

Same Entity

LABTICIAN OPHTHALMICS, 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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612327. Last updated year: 2026. Please use registration number 9612327 when referencing this establishment in official correspondence.