Data / Medical devices / South Korea / Classys Inc

Classys Inc: FDA-registered device maker in Anyang-si Gyeonggi, South Korea, 14 510(k) clearances

Name: Classys Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Classys Inc is registered with the FDA (registration 3010363436) in Anyang-si Gyeonggi, South Korea. It lists 8 device types. The FDA files 14 510(k) clearances under its listings, the newest dated November 20, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010363436
Address: 9F, 25, Deokcheon-ro 152beon-gil Manan-gu, Anyang-si Gyeonggi, South Korea, 14084
Owner or operator: CLASSYS INC (10051595)
Roles: Manufacturer
First device listed: October 24, 2024
Registered through: 2026
Brand names listed: Acutron, CuRAS hybrid, Curas Nd:Yag Laser, Fraxis, Fraxis Duo, QUADESSY, Reepot, Reticapture and more

Devices it lists

Device	Product code	Class	Role	Source
Camera, Ophthalmic, Ac-Powered	HKI	2	Manufacturer	accessdata.fda.gov
Electrosurgical Coagulation For Aesthetic	ONQ	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Epilator, High Frequency, Needle-Type	KCW	1	Manufacturer	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	2	Manufacturer	accessdata.fda.gov
Skin Resurfacing Rf Applicator	OUH	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 20, 2025	K253123	CuRAS hybrid	GEX	Substantially Equivalent	Classys, Inc.	accessdata.fda.gov
November 21, 2024	K241157	Secret MAX Multi-platform RF System	GEI	Substantially Equivalent	Ilooda Co,., Ltd.	accessdata.fda.gov
December 14, 2023	K233374	Secret Pro	GEI	Substantially Equivalent	Ilooda Co,., Ltd.	accessdata.fda.gov
September 23, 2022	K222555	reepot Nd; YAG laser system	GEX	Substantially Equivalent	Ilooda Co,., Ltd.	accessdata.fda.gov
June 24, 2022	K213250	Secret Duo	GEX	Substantially Equivalent	Ilooda Co,., Ltd.	accessdata.fda.gov
June 9, 2022	K211000	ACUTRON	GEI	Substantially Equivalent	Ilooda Co,., Ltd.	accessdata.fda.gov
April 23, 2021	K202043	Secret Duo	GEX	Substantially Equivalent	Ilooda Co,., Ltd.	accessdata.fda.gov
September 6, 2019	K182355	Secret RF Smartcure Applicator with electrodes	GEI	Substantially Equivalent	Ilooda Co,., Ltd.	accessdata.fda.gov
July 27, 2018	K173474	RetiCapture	HKI	Substantially Equivalent	Ilooda Co,., Ltd.	accessdata.fda.gov
December 1, 2017	K173038	CuRAS Nd:YAG Laser	GEX	Substantially Equivalent	Ilooda Co,., Ltd.	accessdata.fda.gov
August 9, 2017	K172096	Fraxis	GEX	Substantially Equivalent	Ilooda Co,., Ltd.	accessdata.fda.gov
June 13, 2017	K170325	SECRET RF	GEI	Substantially Equivalent	Ilooda Co,., Ltd.	accessdata.fda.gov
October 28, 2016	K160312	FRAXIS DUO	GEX	Substantially Equivalent	Ilooda Co,., Ltd.	accessdata.fda.gov
August 6, 2015	K151232	VIKINI Diode Laser System	GEX	Substantially Equivalent	Ilooda Co,., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 20, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.