510(k) Report

FDA applicant

Capillus, LLC

Miami, FL8 decisions2015–20190 recalls

FDA records 8 decisions for Capillus, LLC (Miami, FL) from 2015 to 2019: 8 510(k) clearances. All are in product code OAP (Laser, Comb, Hair). Since 2016 its 510(k)s took a median of 45 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Capillus”.

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 Capillus, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2015: 32016: 32017: 12019: 1
2015high 3 (2015) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

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

Planning a device like Capillus, LLC’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, Hair8decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 45 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 83 days; 5 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 18 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 41 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.

  • K163170Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352Capillus, LLC · 201713cite it
  • K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC · 20168cite it
  • K143199Capillus 272 ProCapillus, LLC · 20158cite it
  • K153618Capillus202Capillus, LLC · 20166cite it
  • K151516Capillus82Capillus, LLC · 20153cite it
  • K150578Capillus 272 Office ProCapillus, LLC · 20151cites it

What has FDA decided for it lately?

  • K192012Capillus 112, Capillus 244Capillus · 2019
  • K163170Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352Capillus, LLC · 2017
  • K162994Capillus302, Capillus312, Capillus352Capillus, LLC · 2016
  • K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC · 2016
  • K153618Capillus202Capillus, LLC · 2016
  • K151516Capillus82Capillus, LLC · 2015
  • K150578Capillus 272 Office ProCapillus, LLC · 2015
  • K143199Capillus 272 ProCapillus, LLC · 2015

All 7 as Capillus, LLC →The one decision as Capillus →