Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015528097

FEI Number

3015528097

Entity Name

RAICO

City/State/Country

Westmont, IL, US

Establishment Address

825 North Cass Avenue, 202, Westmont, IL 60559, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

RAICO (Owner Number: 10060634)

Owner / Operator Contact Address

825 N Cass Ave, Suite 202, Westmont, IL 60559, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HARMONIX Phaco tips RAICO Trabeculotomy Instruments HARMONIX Polymer IA tips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2020-05-27
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2021-01-23
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-06-15

Official Correspondent

Ravi Nallakrishnan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RAICO

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
K091915	Lenstec, Inc.	FLUID ISOLATION DEVICE	2009-10-27
K830812	Alphamedix, Inc.	ALPHAMEDIX I/A HAND-PIECE, 500-001	1983-06-08
K133115	Abbott Medical Optics, Inc.	COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK	2014-02-27
K121721	Abbott Medical Optics, Inc.	LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)	2012-10-15
K111697	Abbott Medical Optics, Inc.	AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM	2011-09-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-1670-2013	Abbott Medical Optics, Inc.	2	Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Z-0099-2024	Alcon Research, LLC	2	Constellation Vision System, REF: 8065751150
Z-0305-2026	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-1794-2020	Alcon Research LLC	2	Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
Z-2109-2025	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A

Similar Registrations

Registration Number	Establishment Name	Location
3013497605	Alcon Research, LLC	Sinking Spring, PA, US
3005012805	MIDWEST STERILIZATION CORP.	LAREDO, TX, US
2028159	Alcon Research, LLC	IRVINE, CA, US
1650907	Isomedix Operations Inc.	GRAND PRAIRIE, TX, US
3003365815	Bausch+Lomb Netherlands B.V. Amsterdam Logistics Centre	SCHIPOL RIJK Noord-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015528097. Last updated year: 2026. Please use registration number 3015528097 when referencing this establishment in official correspondence.