Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009542956

FEI Number

3009542956

Entity Name

Burton Medical LLC

City/State/Country

Addison, IL, US

Establishment Address

2300 W Windsor Ct. STE C, Addison, IL 60101, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Burton Medical LLC (Owner Number: 10040558)

Owner / Operator Contact Address

2300 W Windsor Court, STE C, Addison, IL 60101, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

APEX LED AIM 200, MAJOR SURGICAL LIGHT HL70 "GENIE' SINGLE CEILING AND DOUBLE CEILING APEX AIM 100 MINOR SURGERY LIGHT CoolSpot II Outpatient II SELED OPLED Super Bright Spot LED (SBL) EPIC LED Medichoice Super Exam 50 Super Bright Spot Super Exam 50 AIM 50 Gleamer Medichoice MEDC LED Medichoice Super Exam 50 LED Super Exam 50 LED AIM LED Medichoice MEDC Outpatient Nova Exam LED

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2023-09-13
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2012-04-24
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	Class 1	886.4335	2025-01-02
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2012-04-25
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2012-04-25
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2012-04-27

Official Correspondent

Parameshwaran Balasubramaniam

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Burton Medical LLC

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
K780666	Castle Co.	DAYSTAR SELECTRA & SELECTRA/ORBITER	1978-04-27
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009542956. Last updated year: 2026. Please use registration number 3009542956 when referencing this establishment in official correspondence.