Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1226587

FEI Number

3003046678

Entity Name

HAI LABORATORIES, INC.

City/State/Country

LEXINGTON, MA, US

Establishment Address

320 Massachusetts Ave, LEXINGTON, MA 02420, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

HAI LABORATORIES, INC. (Owner Number: 9040002)

Owner / Operator Contact Address

320 MASSACHUSETTS AVE., --, Lexington, MA 02420, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EB-3000xyz CL-1000eva CL-1000xyz CL-1000nc Eyelid Retractor Capsule Hook Iris Hook Lens Manipulator Strabismus Hook Lens Nucleus Hook IOL Orientation Hook Castroviejo Caliper Irrigation/Aspiration Cannula Needle Scissors Strabismus Scissors Corneal Scissors Ophthalmic Scissors Iris Scissors Tenotomy Scissors Vannas Scissors Enucleation Scissors Scleral Scissors Cataract Scissors Ophthalmic Trephine Cornea Marker Eye Speculum Pediatric Speculum Strabismus Forceps Tying Forceps Penetration Forceps Micro-needle Holder Capsulorhexis Forceps Capsulotomy Forceps IOL Implantation Forceps Corneal Epidermic Forceps Iris Forceps Hemostat Forceps Corneal Scleral Forceps Fixation Forceps Dressing Forceps Suturing Forceps Chalazion Forceps Trachoma Forceps Cilia Forceps Micro-ophthalmic Forceps Corneal Spatula Iris Spatula Cataract Knife Goniotomy Knife Scleral Dissection Knife Dissection Knife Cystotome Knife

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2007-11-23
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-10-29
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-10-29
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-10-29
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-10-29
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-10-29
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-10-29
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-10-29
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-10-29
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-10-29

Official Correspondent

VIVIAN XUE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HAI LABORATORIES, 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
K142953	Optomedical Technologies GmbH	OCT-Camera	2015-03-04
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2018	Optovue, Inc.	2	iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Z-0010-2018	Optovue, Inc.	2	iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
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.

Similar Registrations

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1000379039	HEINE OPTOTECHNIK GMBH & CO. KG.	GILCHING Bavaria, DE
3013298431	VEENAK INTERNATIONAL LIMITED	BIRMINGHAM, GB
3010792309	SOFTCARE CO., LTD.	Fukutsu Fukuoka, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1226587. Last updated year: 2026. Please use registration number 1226587 when referencing this establishment in official correspondence.