Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021839632

FEI Number

1000125341

Entity Name

Medical Illumination International, Inc

City/State/Country

Chatsworth, CA, US

Establishment Address

Office, 19749 Dearborn Street, Chatsworth, CA 91311, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDICAL ILLUMINATION INTERNATIONAL, INC. (Owner Number: 9003847)

Owner / Operator Contact Address

19749 Dearborn St., --, Chatsworth, CA 91311, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

1300 XSBP Xenon Light Source System 2 LED MI 1000 Nuvo Surgical Table Accessories OptiLux LED Illuminator NUVO NAVIGATOR SERIES MI Examination light VIDASHIELD/UV24 Continuous UV-C Antimicrobial Air Purifier Nuvo V-7 Surgical Table B2AV800 Series B2AV1000 Series System One Surgical Camera No Audio IsoLux Surgical Headlight IsoLED Flex Examination Light IsoLED Portable Headlight

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2023-09-25
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2011-03-11
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2011-04-07
HBI	Illuminator, Fiberoptic, Surgical Field	General, Plastic Surgery	Class 2	878.4580	2023-09-25
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2007-11-28
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	1992-06-26
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2021-02-25
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2011-04-07
FWB	Camera, Television, Surgical, Without Audio	General, Plastic Surgery	Class 1	878.4160	2009-03-09
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2023-09-25
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2023-09-25
FCT	Headlight, Fiberoptic Focusing	Ophthalmic	Class 2	886.4335	2024-04-09

Official Correspondent

ROBERT HESS

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDICAL ILLUMINATION INTERNATIONAL, 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
K936071	Smith & Nephew Dyonics, Inc.	SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE	1994-08-19
K953574	American Hydro-Surgical Instruments, Inc.	NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER	1995-09-29
K901491	Cuda Products Co.	CUDA SURGICAL LIGHT	1990-06-18
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0036-2024	Getinge Usa Sales Inc	1	Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021839632. Last updated year: 2026. Please use registration number 3021839632 when referencing this establishment in official correspondence.