Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017435679

FEI Number

3017435679

Entity Name

Hoya Global Distribution Center

City/State/Country

Amphur Siracha, Chonburi Chon Buri, TH

Establishment Address

158/13 Moo 5, Tambol NongKham,, Amphur Siracha, Chonburi Chon Buri 20110, TH

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

HOYA MEDICAL SINGAPORE PTE LTD (Owner Number: 10026402)

Owner / Operator Contact Address

10 Biopolis Road #04-01/06, Chromos, Singapore, SG-01 138670, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P080004

All Registered Proprietary Names

iSert Preloaded IOL System (Model No. 251) iSert Preloaded IOL System (Model No. 250) iSert Preloaded IOL System (Model No. 230) IPure B3PY IPure B1PY IPure B1PC PreVue C IPure B3PC iSert 254 iSymm IOL (Model FC-60AD) iSert Preloaded IOL System (Model PC-60AD) PreVue Y iSert Preloaded IOL System (Model PY-60R) iSymm IOL (Model FY-60AD) iSpheric IOL (Model YA-60BBR) iSert 255 iSert Preloaded IOL System (Model PY-60AD) iSpheric IOL (Model YA-60BB) ezSert 254E ezSert 255E iSert Preloaded IOL System (Model No. 231)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2008-10-13

Official Correspondent

SVETLANA BYKANOVA

US Agent Details

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

Related Public Records

Same Entity

HOYA MEDICAL SINGAPORE PTE LTD

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020977988	HOYA LAMPHUN LTD.	Amphur Muang Lamphun, TH
3007125265	HOYA MEDICAL SINGAPORE PTE LTD	Singapore Central Singapore, SG

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 3017435679. Last updated year: 2026. Please use registration number 3017435679 when referencing this establishment in official correspondence.