Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010148516

FEI Number

3010148516

Entity Name

AI OPTICS PRIVATE LIMITED

City/State/Country

Ambattur, Chennai Tamil Nadu, IN

Establishment Address

84/1, Aavin dairy Farm Road, SIDCO Industrial Estate, Ambattur, Chennai Tamil Nadu 600098, IN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

AI OPTICS PRIVATE LIMITED (Owner Number: 10042127)

Owner / Operator Contact Address

84/1, Aavin Dairy Farm Road, SIDCO Industrial Estate, Ambattur, Chennai, IN-TN 600098, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Unfinished Lens Galaxy Lens

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2024-04-25
KYB	Lens, Guide, Intraocular	Ophthalmic	Class 1	886.4300	2012-10-23

Official Correspondent

Narayanasamy R K

US Agent Details

Jayesh Patel Business: Amstermed Inc Email: info@amstermed.nl Phone: (714) 5954919

Related Public Records

Same Entity

AI OPTICS PRIVATE LIMITED

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-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 3010148516. Last updated year: 2026. Please use registration number 3010148516 when referencing this establishment in official correspondence.