Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006437518

FEI Number

3006437518

Entity Name

DKK DAI-ICHI SHOMEI CO, LTD

City/State/Country

ITABASHI-KU Tokyo, JP

Establishment Address

1-32-26, SAKASHITA, ITABASHI-KU Tokyo 174-0043, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DKK DAI-ICHI SHOMEI CO, LTD (Owner Number: 9042505)

Owner / Operator Contact Address

1-32-26, SAKASHITA,, --, ITABASHI-KU, TOKYO, JP-NOTA 174-0043, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Remote Camera Control Unit Aurora II and newer Camera for Aurora 3 and Aurora Four Lights and Lumos series Lucina4 Series Spectra AUT1 series Aurora Series Aurora 2 Series Nautilus LED Series Stellar Series Stellar XL Series Aurora 3 Series Aurora Astro Series Aurora 4 Series Lumos series Aurora series, Aurora 2 series, Aurora 3 series and Aurora 4 series Aurora Astro Series Lumos series Sterilizable Camera Cover for Various Model Surgical Lights Sterilizable Center Focus Handle Sterilizable Handle/Adapter for Various Model Surgical Lights Nautilus LED series Stellar XL Series

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2016-06-14
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2015-04-22
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2015-12-17
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2007-11-15
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2016-06-14
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2015-04-17

Official Correspondent

No official correspondent registered.

US Agent Details

ALAN SCHWARTZ Business: MDI CONSULTANTS Email: alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

DKK DAI-ICHI SHOMEI CO, LTD

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

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

Similar Registrations

Registration Number	Establishment Name	Location
3010349493	PROMATE SOLUTIONS	Taipei, TW
3035371773	Rocoto Inc.	Irvine, CA, US
3038951686	BROADATA COMMUNICATIONS INC.	Torrance, CA, US
3008648418	ZHENGZHOU HUAER ELECTRO-OPTICS TECHNOLOGY CO., LTD.	Zhengzhou Henan, CN
8043933	BRAINLAB SE	Munich Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006437518. Last updated year: 2026. Please use registration number 3006437518 when referencing this establishment in official correspondence.