Picowon

FDA UDI

Class II (US FDA UDI)

by Wontech Co., Ltd

Identity

Trade Name: Picowon FDA UDI
Generic Name: Dermatological solid-state laser system FDA UDI
Device Name: Alexandrite laser System FDA UDI
Model / Reference: Picowon FDA UDI
Description: Alexandrite laser System FDA UDI

Identifiers

Primary DI / UDI-DI: 08800022304405 FDA UDI
510(k) Number: K201406 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Dermatological solid-state laser system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dermatological solid-state laser system

Picowon by Wontech Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Splendor X — Bios, Inc. · Class II
EPY-50 — DDC TECHNOLOGIES, INC. · Class II
Canister HFC-134a /980g, ALUM, 15 pack — Candela Corporation · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Wontech Co., Ltd

Sources (1)

FDA UDI 4b516eca-af45-4791-9333-7886be83d85e 34 fields · synced May 30, 2026