Data / Medical devices / South Korea / Ids Ltd

Ids Ltd: FDA-registered device maker in Paju Gyeonggi, South Korea, 3 510(k) clearances

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

Ids Ltd is registered with the FDA (registration 3012639861) in Paju Gyeonggi, South Korea. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 5, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012639861
Address: 194 Simgung-Ro Gwangtan-Myeon, Paju Gyeonggi, South Korea, 10952
Owner or operator: IDS LTD (10053355)
Roles: Manufacturer
First device listed: February 4, 2018
Registered through: 2026
Brand names listed: ANGELA Fractional CO2 Laser System; SMAXEL Fractional CO2 Laser System (formally MX-7000 MICROXEL), FRACLIGHT RPL System, HydroQueen, MICROSYS, PROLONG, SHINY PLUS, SHINY RPL System

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	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
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	2	Manufacturer	accessdata.fda.gov
Vibrator For Climax Control Of Premature Ejaculation	PIA	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
October 5, 2018	K181868	SHINY RPL System	ONF	Substantially Equivalent	Ids, Ltd.	accessdata.fda.gov
February 2, 2018	K180036	SMAXEL CO2 Surgical Laser System	ONG	Substantially Equivalent	Ids, Ltd.	accessdata.fda.gov
March 20, 2015	DEN130047	PROLONG	PIA	Unknown	Ergon Medical , Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 16, 2024	96034	Class II	Ongoing	Smaxel Fractional CO2 Laser, a Class IV medical laser system.	The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.	accessdata.fda.gov

Compare with other makers

Updated January 7, 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.