Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014704068

FEI Number

3014704068

Entity Name

MOLECULIGHT INC.

City/State/Country

TORONTO Ontario, CA

Establishment Address

425 UNIVERSITY AVE, TORONTO Ontario M5G1T6, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MolecuLight Inc. (Owner Number: 10058911)

Owner / Operator Contact Address

425 UNIVERSITY AVE, TORONTO, CA-ON M5G1T6, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213840

PMA Number

N/A

All Registered Proprietary Names

i:X Sterile Surgical Sleeve Convenience Kit MolecuLightDX Sterile Sleeve Thermal Imaging Module MolecuLight i:X

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2020-07-08
QJF	Autofluorescence Imaging Adjunct Tool For Wounds	General, Plastic Surgery	Class 2	878.4550	2024-03-01
FXN	Tape, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2024-03-01

Official Correspondent

Jordan John

US Agent Details

Martha Yannessa Email: myannessa@moleculight.com Phone: (412) 2606857

Related Public Records

Same Entity

MolecuLight 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
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0095-2021	Alcon Research, LLC	2	Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

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3015173212	Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, MX
3007007790	Sterigenics Shanghai ETO Ltd.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014704068. Last updated year: 2026. Please use registration number 3014704068 when referencing this establishment in official correspondence.