510(k) Report

FDA applicant

Theradome, Inc.

Pleasanton, CA5 decisions2012–20180 recalls

FDA records 5 decisions for Theradome, Inc. (Pleasanton, CA) from 2012 to 2018: 5 510(k) clearances. All are in product code OAP (Laser, Comb, Hair). Since 2016 its 510(k)s took a median of 87 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Theradome, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2012: 12013: 12016: 12018: 2
2012high 2 (2018) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Theradome, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Theradome, 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?

  • OAPLaser, Comb, Hair5decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 87 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 87 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 5 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.

  • K122950Laser HelmetTheradome, Inc. · 20138cite it
  • K113097Laser HelmetTheradome, Inc. · 20124cite it
  • K161046Laser Helmet LH40-EVOTheradome, Inc. · 20161cites it
  • K171775Theradome LH80 PROTheradome, Inc. · 20181cites it

What has FDA decided for it lately?

  • K180460Theradome LH40Theradome, Inc. · 2018
  • K171775Theradome LH80 PROTheradome, Inc. · 2018
  • K161046Laser Helmet LH40-EVOTheradome, Inc. · 2016
  • K122950Laser HelmetTheradome, Inc. · 2013
  • K113097Laser HelmetTheradome, Inc. · 2012

All 5 as Theradome, Inc. →