510(k) Report

FDA applicant

Heat IN A Click, LLC

Dania, FL8 decisions2015–20250 recalls

FDA records 8 decisions for Heat IN A Click, LLC (Dania, FL) from 2015 to 2025: 8 510(k) clearances. Most are in product codes PBX (Massager, Vacuum, Radio Frequency Induced Heat) and OHS (Light Based Over The Counter Wrinkle Reduction). Since 2016 its 510(k)s took a median of 278 days from receipt to decision, against 177 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Heat IN A Click”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Heat IN A Click, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2015: 12018: 12020: 22021: 12022: 12025: 2
2015high 2 (2020) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Heat IN A Click, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Heat IN A Click, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • PBXMassager, Vacuum, Radio Frequency Induced Heat2decisions
  • OHSLight Based Over The Counter Wrinkle Reduction2decisions
  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter1decision
  • NGXStimulator, Muscle, Powered, For Muscle Conditioning1decision
  • OLPOver-The-Counter Powered Light Based Laser For Acne1decision
  • NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 278 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 177 days; 3 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K1718212 Face / Face EvolutionHeat IN A Click · 20189cite it
  • K202055Looper (Model: ZX-579S)Heat IN A Click, LLC · 20213cite it
  • K191940Palm NRG cellulite and muscle toning body deviceHeat IN A Click · 20201cites it

What has FDA decided for it lately?

  • K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC · 2025
  • K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC · 2025
  • K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC · 2022
  • K202055Looper (Model: ZX-579S)Heat IN A Click, LLC · 2021
  • K191940Palm NRG cellulite and muscle toning body deviceHeat IN A Click · 2020
  • K191938FitRelief TENS&EMS Wireless DeviceHeat IN A Click, LLC · 2020
  • K1718212 Face / Face EvolutionHeat IN A Click · 2018
  • K150308Palm TENSHeat IN A Click, LLC · 2015

All 6 as Heat IN A Click, LLC →All 2 as Heat IN A Click →