Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003984265

FEI Number

3003984265

Entity Name

POTEC CO., LTD.

City/State/Country

DAEJEON, KR

Establishment Address

40-4, Techno 2-ro, Yuseong-gu, DAEJEON 305-509, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

POTEC CO., LTD. (Owner Number: 9059372)

Owner / Operator Contact Address

40-4, Techno 2-ro, Yuseong-gu, --, DAEJEON, KR-30 34015, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

POTEC PRK 5000 POTEC PRK-5000L POTEC PRK-7000 POTEC PRK-8000 EZER ERK-BH EZER ERK-H HRK-9900 HRK-9000 POTEC PRK-6000 POTEC PRK-9000 POTEC PLM-8000PD POTEC PLM-8000 POTEC PLM-6100 POTEC PLM-6100 PD EZER ELM-BH EZER ELM-BH-PD POTEC PLM-6000 POTEC PACP-6000 POTEC PACP-7000L POTEC PLC-7100 POTEC PLC-7100pola POTEC PLC-8000 Polar POTEC PLC-8000 POTEC PLC-7000 POTEC PACP-7000 POTEC PLC-7000 Polar PACP-8000 EZER EDC-BH POTEC PLC-9000 Polar POTEC PACP-6100 POTEC PLC-9000 POTEC PDR-7000 VISION TESTER POTEC PAV-6100 Digital refractor EZER EDR-H

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKO	Refractometer, Ophthalmic	Ophthalmic	Class 1	886.1760	2003-10-28
HLM	Instrument, Measuring, Lens, Ac-Powered	Ophthalmic	Class 1	886.1425	2004-11-30
HOS	Projector, Ophthalmic	Ophthalmic	Class 1	886.1680	2004-11-30
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	Class 1	886.1770	2006-09-19

Official Correspondent

Harry Hazra

US Agent Details

Gustavo Lancewicki Business: US Ophthalmic LLC Email: g.lancewicki@usophthalmic.com Phone: (305) 5034091

Related Public Records

Same Entity

POTEC CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003984265. Last updated year: 2026. Please use registration number 3003984265 when referencing this establishment in official correspondence.