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Numiere 6664

by Heat in a Click LLC

Numiere 6664 is a home-use radio-frequency skin contouring unit (FDA Class II; FDA product code PBX, Massager, Vacuum, Radio Frequency Induced Heat) made by Heat in a Click LLC, cleared under FDA 510(k) K214015 on 26 Sep 2022 and listed in FDA GUDID since 31 Jan 2025 (UDI-DI 00850018806664), active as of 23 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 23 Oct 2026

Documents

510(k) K214015

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850018806664 UDI-DI Date31 Jan 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK214015 Date26 Sep 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K214015 decided 26 Sep 2022 Active
  • FDA GUDID UDI-DI 00850018806664 listed 31 Jan 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K214015
  2. Listed FDA GUDID 00850018806664

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Numiere
Generic name
Home-use radio-frequency skin contouring unit
Model / reference
6664
Primary DI / UDI-DI
00850018806664
510(k) Number
FDA product code
PBX
GMDN term
Home-use radio-frequency skin contouring unit
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Home-use radio-frequency skin contouring unit

Cleared under the same submission (K214015)

Similar devices

Other devices filed under FDA product code PBX (Massager, Vacuum, Radio Frequency Induced Heat).

Other devices from Heat in a Click LLC

  • Lumina NRG 6626

    Class II

  • Numiere 6824

    Class II

  • Lumina NRG 6572

    Class II

  • Numiere 6701

    Class II

See all devices from Heat in a Click LLC →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)