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Numiere 6701

by Heat in a Click LLC

Numiere 6701 is a red-light phototherapy unit (FDA Class II; FDA product code OHS, Light Based Over The Counter Wrinkle Reduction) made by Heat in a Click LLC, cleared under FDA 510(k) K241857 on 11 Oct 2024 and listed in FDA GUDID since 31 Jan 2025 (UDI-DI 00850018806701), 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) K241857

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 Number00850018806701 UDI-DI Date31 Jan 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241857 Date11 Oct 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241857 decided 11 Oct 2024 Active
  • FDA GUDID UDI-DI 00850018806701 listed 31 Jan 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K241857
  2. Listed FDA GUDID 00850018806701

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  • Withdrawn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
Red-light phototherapy unit, home-use
Model / reference
6701
Primary DI / UDI-DI
00850018806701
510(k) Number
FDA product code
OHS
GMDN term
Red-light phototherapy unit, home-use
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Red-light phototherapy unit, home-use

Similar devices

Also classified as Red-light phototherapy unit, home-use.

Similar devices

Other devices filed under FDA product code OHS (Light Based Over The Counter Wrinkle Reduction).

Other devices from Heat in a Click LLC

  • Numiere 6664

    Class II

  • Lumina NRG 6626

    Class II

  • Numiere 6824

    Class II

  • Lumina NRG 6572

    Class II

See all devices from Heat in a Click LLC →

Properties

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