Picowon

by Wontech Co., Ltd

Picowon is a Class II device made by Wontech Co., Ltd, cleared under FDA 510(k) K201406 on 22 Jul 2020 and listed in FDA GUDID since 6 Oct 2020 (UDI-DI 08800022304405), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08800022304405 UDI-DI	Date6 Oct 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK201406	Date22 Jul 2020Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08800022304405
FDA 510(k) database 510(k) number K201406

Across registries

2 registries list this device

FDA 510(k) K201406 decided 22 Jul 2020 Active
FDA GUDID UDI-DI 08800022304405 listed 6 Oct 2020 Listed

Timeline

2 dated events

22 Jul 2020 Cleared FDA 510(k) K201406
6 Oct 2020 Listed FDA GUDID 08800022304405

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Dermatological solid-state laser system
Model / reference: Picowon

Primary DI / UDI-DI: 08800022304405
510(k) Number: K201406
FDA product code: GEX
GMDN term: Dermatological solid-state laser system

Device class: Class II
Regulation number: 878.4810
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)