Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006799849

FEI Number

3006799849

Entity Name

XENOSYS CO., LTD.

City/State/Country

Incheon, KR

Establishment Address

2, VENTURE-RO, 100 BEON-GIL,, YEONSU-GU,, Incheon 22013, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

XENOSYS CO., LTD. (Owner Number: 10023214)

Owner / Operator Contact Address

2, Venture-ro, 100 Beon-gil,, Yeonsu-gu, Incheon, KR-28 22013, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LooksCAM1 Looks & LooksA L2SW & L2SWE L2S14C L2SX6 LooksCAM2 Lookscam LT XDL4 L2S15 L2SX5 L2SX5

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FWJ	Camera, Cine, Microsurgical, Without Audio	General, Plastic Surgery	Class 1	878.4160	2010-11-08
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	2007-11-11
FSQ	Light, Surgical, Instrument	General, Plastic Surgery	Class 2	878.4580	2015-10-20
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2012-04-03
FWC	Camera, Television, Surgical, With Audio	General, Plastic Surgery	Class 1	878.4160	2014-08-05
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2026-02-10
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2012-04-22
EBA	Light, Surgical Headlight	Dental	Class 1	872.4630	2021-01-28

Official Correspondent

Hadeuk Lee

US Agent Details

David Thomas Business: R&D Surgical USA Inc Email: david@randdsurgical.com Phone: (512) 5390602

Related Public Records

Same Entity

XENOSYS 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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-2412-2024	Alcon Research LLC Aspex Facility	1	Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

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3010208880	Alcon Research, LLC	Lake Forest, CA, US
3012060713	EMBEDTEK, LLC	Waukesha, WI, US
2028159	Alcon Research, LLC	IRVINE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006799849. Last updated year: 2026. Please use registration number 3006799849 when referencing this establishment in official correspondence.