Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012259264

FEI Number

3012259264

Entity Name

CLASSYS INC

City/State/Country

Republic of Korea Seoul, KR

Establishment Address

208, Teheran-ro, Gangnam-gu, Republic of Korea Seoul 06220, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CLASSYS INC (Owner Number: 10051595)

Owner / Operator Contact Address

CLASSYS, 208, Teheran-ro, Gangnam-gu, Seoul, KR-11 06220, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230100

PMA Number

N/A

All Registered Proprietary Names

SCIZER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHV	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption	General, Plastic Surgery	Class 2	878.4590	2023-12-15

Official Correspondent

No official correspondent registered.

US Agent Details

Dana S Email: dana@elexes.com Phone: (732) 6475105

Related Public Records

Same Entity

CLASSYS INC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010363436	CLASSYS INC	Anyang-si Gyeonggi, KR

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012259264. Last updated year: 2026. Please use registration number 3012259264 when referencing this establishment in official correspondence.