Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008344633

FEI Number

3008344633

Entity Name

HOYA SURGICAL RESEARCH CENTER

City/State/Country

Tokyo, JP

Establishment Address

Helios II Bldg ,3F 1-12-11, Funado, Itabashi-ku, Tokyo 174-0041, JP

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Hoya Surgical Research Center (Owner Number: 10032157)

Owner / Operator Contact Address

6-10-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, JP-13 160-8347, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K081346

PMA Number

N/A

All Registered Proprietary Names

iSert preloaded IOL System (Model No. 251) iSert preloaded IOL System (Model No. 250) iSymm IOL (Model FC-60AD) iSymm IOL (Model FY-60AD) iSert preloaded IOL System (Model No. 230) iSert preloaded IOL System (Model No. 231) IPure B1PC IPure B3PC IPure B3PY IPure B1PY Hoya-IS Injector System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2016-12-07
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2010-04-14

Official Correspondent

Toru Yoshitomi

US Agent Details

Rekha Janarthanan Business: Hoya Surgical Optics Email: rekha.janarthanan@hoya.com Phone: (949) 8420193

Related Public Records

Same Entity

Hoya Surgical Research Center

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0275-2012	Abbott Medical Optics Inc (AMO)	3	Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
Z-0276-2012	Abbott Medical Optics Inc (AMO)	3	Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
Z-0605-2010	Abbott Medical Optics Inc (AMO)	3	AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
Z-0929-2013	Abbott Medical Optics Inc (AMO)	3	AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.
Z-2287-2020	Alcon Research LLC Aspex Facility	3	Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008344633. Last updated year: 2026. Please use registration number 3008344633 when referencing this establishment in official correspondence.