Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010363436

FEI Number

3010363436

Entity Name

CLASSYS INC

City/State/Country

Anyang-si Gyeonggi, KR

Establishment Address

9F, 25, Deokcheon-ro 152beon-gil, Manan-gu, Anyang-si Gyeonggi 14084, 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

K222555

PMA Number

N/A

All Registered Proprietary Names

Secret Rf Smartcure Applicator With Electrodes Secret Duo CuRAS hybrid Secret Pro Fraxis Duo Curas Nd:Yag Laser Secret Duo Vikini Diode Laser System Acutron Secret Pro Reepot

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCW	Epilator, High Frequency, Needle-Type	General, Plastic Surgery	Class 1	878.5350	2024-10-29
ONQ	Electrosurgical Coagulation For Aesthetic	General, Plastic Surgery	Class 2	878.4400	2024-10-29
OUH	Skin Resurfacing Rf Applicator	General, Plastic Surgery	Class 2	878.4400	2024-10-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-10-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-10-29
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-10-29
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2026-01-20
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-10-29
OUH	Skin Resurfacing Rf Applicator	General, Plastic Surgery	Class 2	878.4400	2024-10-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-10-29
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-10-29
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-10-29
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2024-10-29
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-10-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-10-29
OUH	Skin Resurfacing Rf Applicator	General, Plastic Surgery	Class 2	878.4400	2024-10-29
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-10-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-10-29
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-10-28

Official Correspondent

James Lim

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
3012259264	CLASSYS INC	Republic of Korea Seoul, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K954031	R. A. Fischer Co. Corp.	COMPU-BLEND EPILATOR	1996-01-05
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010363436. Last updated year: 2026. Please use registration number 3010363436 when referencing this establishment in official correspondence.