Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009646326

FEI Number

3009646326

Entity Name

ICARES MEDICUS, INC.

City/State/Country

Zhubei Hsinchu, TW

Establishment Address

4F, No.16, Sec. 2, Sheng Yi Road., Zhubei, Hsinchu 30261 Taiwan, R.O.C., Zhubei Hsinchu 30261, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ICARES Medicus, Inc. (Owner Number: 10047474)

Owner / Operator Contact Address

4F, No.16, Sec. 2, Sheng Yi Road., Zhubei, Hsinchu 30261 Taiwan, R.O.C., Zhubei, TW-HSQ 30261, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

lioli IOL Delivery System pioli IOL Delivery System bioli IOL Delivery System BL-Cart IOL Delivery Cartridge

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	2015-11-16
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2018-01-29
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2020-06-30
KYB	Lens, Guide, Intraocular	Ophthalmic	Class 1	886.4300	2014-09-14
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2019-10-08

Official Correspondent

Amanda Lu

US Agent Details

William Lee Business: AST Products, Inc. Email: wlee@astp.com Phone: (978) 6674500

Related Public Records

Same Entity

ICARES Medicus, 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
K823222	American Medical Optics	INTRAOCULAR LENS GUIDE	1982-12-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0835-2025	Alcon Research LLC	1	Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A

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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 3009646326. Last updated year: 2026. Please use registration number 3009646326 when referencing this establishment in official correspondence.