510(k) Report

FDA applicant

Led Technologies, Inc.

Greenwood Village, CO15 decisions2008–20221 recall

FDA records 15 decisions for Led Technologies, Inc. (Greenwood Village, CO) from 2008 to 2022: 15 510(k) clearances. Most are in product codes OHS (Light Based Over The Counter Wrinkle Reduction) and OLP (Over-The-Counter Powered Light Based Laser For…). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 129 for FDA’s reviews in the same codes and years. Its devices cite 30 predicates, 21 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Led Technologies, LLC”.

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 Led Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2008: 12010: 12015: 12017: 22018: 42019: 22021: 22022: 2
2008high 4 (2018) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2008high 1 (2016) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Led Technologies, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • OHSLight Based Over The Counter Wrinkle Reduction11decisions
  • OLPOver-The-Counter Powered Light Based Laser For Acne3decisions
  • ILYLamp, Infrared, Therapeutic Heating1decision

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 88 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 129 days; 5 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 30 predicates; 21 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 33 times; 21 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.

  • K171390dpl II PanelLed Technologies, Inc. · 20176cite it
  • K141181Nuve for Wrinkles, DPL Nuve for WrinklesLed Technologies, LLC · 20155cite it
  • K172662reVive PerioralLed Technologies, Inc. · 20184cite it
  • K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc. · 20184cite it
  • K171386dpl SpectraLiteLed Technologies, Inc. · 20173cite it
  • K180320dpl IIa PanelLed Technologies, Inc. · 20182cite it

What has FDA decided for it lately?

  • K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc. · 2022
  • K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc. · 2022
  • K210968reVive Light Therapy EssentialsLed Technologies, Inc. · 2021
  • K210965reVive Light Therapy EssentialsLed Technologies, Inc. · 2021
  • K183247dpl FacewareLed Technologies, Inc. · 2019
  • K183118dpl SpotLiteLed Technologies, Inc. · 2019
  • K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc. · 2018
  • K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc. · 2018

All 12 as Led Technologies, Inc. →All 3 as Led Technologies, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K081570reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The…Mar 30, 2016Class II