Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006723646

FEI Number

3006723646

Entity Name

HOYA SURGICAL OPTICS, INC.

City/State/Country

Irvine, CA, US

Establishment Address

110 Progress Ave., Suite 175, Irvine, CA 92618, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Hoya Surgical Optics, Inc. (Owner Number: 10026397)

Owner / Operator Contact Address

110 Progress Ave., Suite 175, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P080004

All Registered Proprietary Names

Hoya-IS Injectors and Cartridges (Cartridge Model No. E1) Hoya-IS Injector and Cardtridges (Model No. ISH001, ISH003) iSert Preloaded IOL System (Model 250) iSert Preloaded IOL System (Model 251) IPure B3PC IPure B1PY iSert Preloaded IOL System (Model PY-60R) IPure B3PY iSert Preloaded IOL System (Model PC-60AD) iSymm IOL (Model FC-60AD) IPure B1PC PreVue C iSymm IOL (Model FY-60AD) PreVue Y iSpheric IOL (Model YA-60BBR) iSert Preloaded IOL System (Model PY-60AD) iSpheric IOL (Model YA-60BB) iSert Preloaded IOL System (Model No. 231) iSert Preloaded IOL System (Model No. 230)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2009-03-24
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2009-01-21

Official Correspondent

Rekha Janarthanan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hoya Surgical Optics, Inc.

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.

Similar Registrations

Registration Number	Establishment Name	Location
2523835	Alcon Research, LLC	Sinking Spring, PA, US
3012236936	Johnson & Johnson Surgical Vision, Inc.	Irvine, CA, US
1610287	Alcon Research, LLC	Fort Worth, TX, US
9681862	MEDICEL AG	Altenrhein Sankt Gallen, CH
1932180	Bausch & Lomb Incorporated	Manchester, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006723646. Last updated year: 2026. Please use registration number 3006723646 when referencing this establishment in official correspondence.