Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012639861

FEI Number

3012639861

Entity Name

IDS LTD

City/State/Country

Paju Gyeonggi, KR

Establishment Address

194 Simgung-Ro, Gwangtan-Myeon, Paju Gyeonggi 10952, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IDS LTD (Owner Number: 10053355)

Owner / Operator Contact Address

194, Simgung-ro, Gwangtan-myeon, Paju-si, KR-41 10952, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180036

PMA Number

N/A

All Registered Proprietary Names

PROLONG ANGELA Fractional CO2 Laser System; SMAXEL Fractional CO2 Laser System (formally MX-7000 MICROXEL) MICROSYS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PIA	Vibrator For Climax Control Of Premature Ejaculation	Gastroenterology, Urology	Class 2	876.5025	2020-02-03
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2018-02-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2018-02-04

Official Correspondent

No official correspondent registered.

US Agent Details

SEAN LEE Email: drseanlee74@gmail.com Phone: (913) 2008711

Related Public Records

Same Entity

IDS LTD

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3034246188	IDS LTD	Geumcheon-gu Seoul, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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

Similar Registrations

Registration Number	Establishment Name	Location
3016159407	D-PUB Electronic & Technology Co. Ltd	Huizhou Guangdong, CN
3033790325	DAKA INTERNATIONAL LIMITED	Kowloon Hong Kong, CN
3006247712	Lutronic Aesthetics, Inc.	Westford, MA, US
3004483538	LUTRONIC CORPORATION	Goyang-si Gyeonggi, KR
3043047259	BLINK BRIGHT MEDICAL, INC.	Houston, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012639861. Last updated year: 2026. Please use registration number 3012639861 when referencing this establishment in official correspondence.