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NEWA PLUS Kit Plus, Lavender

by Endymed Medical Ltd

NEWA PLUS Kit Plus, Lavender (ND_PRD00438-00) is a home-use radio-frequency skin contouring unit (FDA Class II; FDA product code PAY, Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction) made by Endymed Medical Ltd, listed in FDA GUDID since 24 Nov 2019 (UDI-DI 07290014660014), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290014660014 UDI-DI Date24 Nov 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
NEWA PLUS Kit
Generic name
Home-use radio-frequency skin contouring unit
Model / Ref / Catalog
Plus, Lavender, ND_PRD00438-00
Primary DI / UDI-DI
07290014660014
FDA product code
PAY
GMDN term
Home-use radio-frequency skin contouring unit
Device class
Class II
Regulation number
878.4420
GUDID distribution status
In Commercial Distribution

Related devices

Category: Home-use radio-frequency skin contouring unit

Similar devices

Other devices filed under FDA product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction).

Other devices from Endymed Medical Ltd

See all devices from Endymed Medical Ltd →

Properties

  • Over-the-counter
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)