Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017609685

FEI Number

3017609685

Entity Name

BIO OPTICS CO., LTD.

City/State/Country

Seongnam Gyeonggi, KR

Establishment Address

14, Galmachi-ro, 288beon-gil, Seongnam Gyeonggi 13201, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bio Optics Co., Ltd. (Owner Number: 10077954)

Owner / Operator Contact Address

14, Galmachi-ro, 288beon-gil, Seongnam, KR-41 13201, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241229

PMA Number

N/A

All Registered Proprietary Names

Hello, eyes - BIO Surgical Knife Hello, eyes - BIO Color Tear Test Hello,eyes (Bio Plug 0.3, Bio Plug 0.4, Bio Plug 0.5)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-10-29
KYD	Strip, Schirmer	Ophthalmic	Class 1	886.1800	2020-10-06
LZU	Plug, Punctum	Unknown	Class U	N/A	2024-07-16

Official Correspondent

Seo Hongryul

US Agent Details

Jung Ryun Ahn Business: KMC USA, Inc Email: kmc.usa@kmcerti.com Phone: (646) 3576058

Related Public Records

Same Entity

Bio Optics 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
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

Similar Registrations

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3012644327	CORE SURGICAL LIMITED	Thame Oxfordshire, GB
8031019	ANTON MEYER & CO. AG	Port Bern, CH
8010851	BERNHARD FREY	TUTTLINGEN Baden-Wurttemberg, DE
2029275	Sterigenics U.S., LLC	Corona, CA, US
9681540	ULTRA SURGICAL (PVT.) LTD	SIALKOT Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017609685. Last updated year: 2026. Please use registration number 3017609685 when referencing this establishment in official correspondence.