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NOUVADerm

FDA UDI

Class II (US FDA UDI)

by Wontech Co., Ltd

Identity

Trade Name
NOUVADerm FDA UDI
Generic Name
General/multiple surgical solid-state laser system FDA UDI
Device Name
Tm-doped Fiber Laser System FDA UDI
Model / Reference
NOUVADerm FDA UDI
Description
Tm-doped Fiber Laser System FDA UDI

Identifiers

Primary DI / UDI-DI
08800022301121 FDA UDI
510(k) Number
K223727 FDA UDI
K241406 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General/multiple surgical 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General/multiple surgical solid-state laser system

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

Similar devices

Also classified as General/multiple surgical solid-state laser system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wontech Co., Ltd

Sources (1)

  • FDA UDI 84a50f5e-7c5f-46a6-88ce-b95f2a455fc6 34 fields · synced Jun 6, 2026