Skip to content

NOUVADerm

by Wontech Co., Ltd

NOUVADerm is a Class II device made by Wontech Co., Ltd, cleared under FDA 510(k) K241406 on 28 Jun 2024 (1 earlier submission) and listed in FDA GUDID since 4 Oct 2024 (UDI-DI 08800022301121), active as of 20 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 20 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 20 Oct 2026.

Regulatory status

as of registry sync 20 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800022301121 UDI-DI Date4 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241406 Date28 Jun 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241406 decided 28 Jun 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08800022301121 listed 4 Oct 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K223727
  2. Cleared FDA 510(k) K241406
  3. Listed FDA GUDID 08800022301121

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
General/multiple surgical solid-state laser system
Model / reference
NOUVADerm
Primary DI / UDI-DI
08800022301121
510(k) Number
FDA product code
GEX
GMDN term
General/multiple surgical solid-state laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: General/multiple surgical solid-state laser system

Similar devices in this category

Other devices filed under General/multiple surgical solid-state laser system.

Other devices from Wontech Co., Ltd

  • Oligio

    Class IIb

  • Tightan Pro

    Class IIa

  • Air Gap Fiber AG365

    Class II

  • V-Laser

    Class II

See all devices from Wontech Co., Ltd →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)