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ZIIP Beauty DOT - Grey

by Ziip, Llc

ZIIP Beauty DOT - Grey is a facial muscle cosmesis electrical stimulator (FDA Class II; FDA product code NFO, Stimulator, Transcutaneous Electrical, Aesthetic Purposes) made by Ziip, Llc, cleared under FDA 510(k) K212342 on 23 Sep 2021 and listed in FDA GUDID since 7 Aug 2025 (UDI-DI 00851367006194), active as of 22 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 22 Oct 2026

Documents

510(k) K212342

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851367006194 UDI-DI Date7 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK212342 Date23 Sep 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K212342 decided 23 Sep 2021 Active
  • FDA GUDID UDI-DI 00851367006194 listed 7 Aug 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212342
  2. Listed FDA GUDID 00851367006194

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ZIIP Beauty
Generic name
Facial muscle cosmesis electrical stimulator
Model / reference
DOT - Grey
Primary DI / UDI-DI
00851367006194
510(k) Number
FDA product code
NFO
GMDN term
Facial muscle cosmesis electrical stimulator
Device class
Class II
Regulation number
882.5890
GUDID distribution status
In Commercial Distribution

Related devices

Category: Facial muscle cosmesis electrical stimulator

Cleared under the same submission (K212342)

and 3 more cleared under K212342

Similar devices

Other devices filed under FDA product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

Other devices from Ziip, Llc

See all devices from Ziip, Llc →

Properties

  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)