Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013202565

FEI Number

3013202565

Entity Name

AAREN SCIENTIFIC INC

City/State/Country

Rancho Cucamonga, CA, US

Establishment Address

9010 Hellman Ave, Rancho Cucamonga, CA 91730, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Aaren Laboratories LLC (Owner Number: 10053459)

Owner / Operator Contact Address

9010 Hellman Avenue, Rancho Cucamonga, CA 91730, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HQ-204 HQ-201 HXP 50C HQ 201 HEP BIOVUE 4 OPTIVIS HSP 65A2 HSP 55B HQ-203 HSP 65A X55125H X55120 HSP 65A2L HQ 201 XO HQ 204 HEP HQ 204 AQUA SENSE III AQUA SENSE AQUA SENSE4 HQ 203 130 XO AQUA SENSE Y AQUA SENSE PAL CENTRIX BIOVUE 3 HQ 203 HEP HQ-203 130 AQUA 4 AQUA 4 RMR BIOVUE PAL HQ 201Y AQUA SENSE III PAL X65130H BIOVUE 3 PAL HQ 200 Y X5020H X601302N BIOVUE 4 PAL X651302H AQUA 4 RM BIOVUE HSP 65A2N AQUA SENSE III-130 PAL X60130 X601302L AQUA SENSE Y PAL AQUA 4 YRM X65130 X65125H HQ 201 Y XO X651302NH X651302 X651302LH HQ 200 X601302

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2016-12-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Aaren Laboratories LLC

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 3013202565. Last updated year: 2026. Please use registration number 3013202565 when referencing this establishment in official correspondence.