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Wontech Co., Ltd

Active in EUDAMED
Also registered as Wontech

South Koreafrom SRN EUDAMED SRN KR-MF-000016169

Wontech Co., Ltd is a medical device manufacturer based in South Korea, with 56 devices listed in FDA 510(k), FDA GUDID and EUDAMED (FDA Class II; EU Class IIa and IIb) as of 13 Nov 2026.

Devices
56
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA 510(k) 29
  • FDA GUDID 28
  • EUDAMED 9

A device listed in two registries counts in both.

Device classes
  • FDA Class II 54
  • EU Class IIa 1
  • EU Class IIb 1
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN KR-MF-000016169
  • DUNS 695658263

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

What Wontech Co., Ltd makes

Wontech Co., Ltd. manufactures single-use and reusable laser systems for surgical and dermatological procedures, including solid-state and frequency-doubled laser devices. Their portfolio includes general surgical laser beam guides, hair growth laser devices, and radio-frequency skin contouring systems, as well as dermatological laser treatments. Examples include handheld hair removal devices (e.g., Hair Boom series) and laser systems like the NOUVADerm and Picocare for skin rejuvenation.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI databases.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue56

Newest first, rows 1-50 of 56

Search and filter all 56 devices
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  • Oligio Ref Radio Frequency Therapy System

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Tightan Pro Ref Focused Ultrasound Stimulator System

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIa

  • NOUVADerm

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Air Gap Fiber AG365

    Active Regimes: 510(k) Registry: GUDID Class:II

  • V-Laser

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Hair Boom69, Hair Beam Air, Hair Boom, Hair Boom Air, Ulike Hair UpUp

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Oligio X

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Picocare

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • WONTECH Surgical Optic Fibers BA400R

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Holinwon 30, HolinWON Prima

    Active Regimes: 510(k) Registry: GUDID Class:II

  • SANDRO Dual

    Active Regimes: 510(k) Registry: GUDID Class:II

  • The Oligio

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Air Gap Fiber AG275

    Active Regimes: 510(k) Registry: GUDID Class:II

  • WONTECH Surgical Optic Fibers BA600

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Picoandy

    Active Regimes: 510(k) Registry: GUDID Class:II

  • WONTECH Surgical Optic Fibers BA400

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Hair Boom69, Hair Boom

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Picowon

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Air Gap Fiber AG550

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Picocaremajesty

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Pastelle Pro

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Hair Boom

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Cosjet SR

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Pastelle

    Active Regimes: 510(k) Registry: GUDID Class:II

  • ALMA VEIL; V-Laser

    Active Regimes: 510(k) Registry: GUDID Class:II

  • WONTECH Surgical Optic Fibers BA600R

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Picocare Family, Picocare450

    Active Regimes: 510(k) Registry: GUDID Class:II

  • SANDRO Dual Ref K252877

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hair Boom 69 Ref K191154

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Air Gap Fiber Ref K232106

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Picocare Family Ref K181272

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Oligio X Ref K240313

    Active Regimes: CE MDD 510(k) Registry: 510(k) Class:II

  • Alma Veil Ref K251094

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • V-Laser Ref K183156

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • V-Laser Ref K221427

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom Ref K240064

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Picocare Ref K162755

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Lavieen Ref K241406

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Picoalex Ref K243957

    Active Regimes: CE MDD 510(k) Registry: EUDAMED510(k)GUDID Class:II

  • WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) Ref K241643

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Picowon Ref K201406

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Oligio X Ref K243929

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • PICOANDY (Q-Switched Nd:YAG Laser) Ref K234104

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • The Oligio Ref K221989

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pastelle Ref K250165

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Picocaremajesty Ref K212127

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Veincare Ref K251288

    Active Regimes: 510(k) Registry: 510(k)GUDID Class:II

  • Picosecond Nd:YAG Laser (PICOCAREMAJESTY) Ref K241144

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Holinwon 30 Ref K183563

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hair Boom 69 Ref K182562

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-50 of 56

Showing 1-50 of 56

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
KR-MF-000016169
DUNS number
695658263
EUDAMED status
Active
EUDAMED registered name
WON TECH Co., Ltd
Registered address
64, Techno8ro, Yuseung-gu, 34028, Daejeon, South Korea
PRRC contact
Hyun Sik Yoon(public in EUDAMED)

Sites1

Frequently asked questions

How many devices does WONTECH CO., LTD have in the registry?

The registry currently lists 56 devices for WONTECH CO., LTD. Devices recorded under merged duplicate company entries are counted once.

Which registries list WONTECH CO., LTD's devices?

Among its 50 most recently registered devices, WONTECH CO., LTD has devices listed in EUDAMED (8 devices), FDA 510(k) (23 devices) and FDA GUDID (27 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do WONTECH CO., LTD's devices fall under?

Among its 50 most recently registered devices, the classes recorded for WONTECH CO., LTD's devices are Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.

What are the newest devices from WONTECH CO., LTD in the registry?

The most recently registered devices listed for WONTECH CO., LTD include Oligio, Tightan Pro, NOUVADerm and Air Gap Fiber AG365.

Generated automatically from registry data and not verified by a human reviewer.