Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006985208

FEI Number

3006985208

Entity Name

WONTECH Co., Ltd.

City/State/Country

Daejeon, KR

Establishment Address

64, Techno 8-ro, Yuseong-gu, Daejeon 305-500, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

WONTECH Co., Ltd. (Owner Number: 10025342)

Owner / Operator Contact Address

64, Techno 8-ro, Yuseong-gu, Daejeon, KR-30 34028, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243929

PMA Number

N/A

All Registered Proprietary Names

Sandro Dual PICOALEX Lavieen Picocare Picowon PICOALEX Pastelle PICOCAREMAJESTY PICOCAREMAJESTY PICOANDY Picocare Family Ulike Hair UpUp Hair Boom 69 Hair Boon Air Hair Boom V-Laser ALMA VEIL Hair Boom Air Hair Beam Air Hair Boom Hair Boom Air Hair Boom Ulike Hair UpUp Hair Boom 69 Veincare Holinwon 30 Holinwon Prima ALMA VEIL AG550 Air Gap Fiber AG365 AG275 Veincare PICOANDY Pastelle V-Laser Hair Beam Air Hair Boom Hair Beam Hair Boom Air V-Laser Hair Boom Air Hair Boom Hair Boom 69 Ulike Hair UpUp Oligio X

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-05-27
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-03-17
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-09-17
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2017-08-08
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-07-22
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2013-05-03
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-01-11
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-06-27
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2018-08-03
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2018-11-19
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-09-18
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2024-02-20
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2019-10-09
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-05-16
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-09-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-05-14
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-01-22
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-12-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-03-18
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-07-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-12-13
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2024-02-20
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-05-19
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2019-07-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-02-14

Official Correspondent

Hyunsik Yoon

US Agent Details

Minsoo Park Email: soo@wtlaser.com Phone: (714) 5829668

Related Public Records

Same Entity

WONTECH Co., Ltd.

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

View Entity Profile →

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
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

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006985208. Last updated year: 2026. Please use registration number 3006985208 when referencing this establishment in official correspondence.