Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1226074

FEI Number

3002616700

Entity Name

Microspecialties LLC

City/State/Country

Middletown, CT, US

Establishment Address

430 Smith St, Middletown, CT 06457, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

MICROSPECIALTIES LLC (Owner Number: 10053719)

Owner / Operator Contact Address

430 Smith Street, Middletown, CT 06457, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PROPAK Injection Kit Keratome Blade Keratome Blade PRO SHIELD Keratome Blade COMFORTEAR PUNCTUM PLUG MICROKARE Knife Fixator PRO-PAKS PRO MARKING PEN PRO-PAKS I Trays Keratome Blade MK800800 (Plano-10,-20,-30,-40) Calibrated Nidek Blades MK101101 (Plano, -10,-20,-30,-40,+10,+20) Calibrated XP Blade MICROkeratome Tubing Keratome Blade PRO-DRAPE PRO EYE SHIELD Sponge Ophthalmic Cellulose and PVA wipes Wicks , shields, drains and spears

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2024-06-25
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2017-01-04
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2017-01-04
MOE	Collagen Corneal Shield	Ophthalmic	Class 1	886.4750	2018-01-12
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2020-01-07
LZU	Plug, Punctum	Unknown	Class U	N/A	2017-01-06
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2017-07-31
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2022-01-14
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2022-01-14
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2019-09-04
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2018-01-12
PZG	Surgical Eye Tray	Ophthalmic	Class 1	886.4350	2026-06-02
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2017-01-04
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2024-05-28
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2017-01-06
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2017-01-06
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2019-09-04
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2018-01-12
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2017-01-06

Official Correspondent

Steve Levesque

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MICROSPECIALTIES 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
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20
K223112	Smith & Nephew, Inc.	MAVERICK Mini External Fixation System	2022-12-08
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1226074. Last updated year: 2026. Please use registration number 1226074 when referencing this establishment in official correspondence.