510(k) Report

FDA applicant

Freedom Laser Therapy, Inc.

Irvine, CA4 decisions2016–20220 recalls

FDA records 4 decisions for Freedom Laser Therapy, Inc. (Irvine, CA) from 2016 to 2022: 4 510(k) clearances. All are in product code OAP (Laser, Comb, Hair). Since 2016 its 510(k)s took a median of 124 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 3 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 Freedom Laser Therapy, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2016: 12019: 12021: 12022: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Freedom Laser Therapy, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Freedom Laser Therapy, Inc.’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?

  • OAPLaser, Comb, Hair4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 124 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 89 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 3 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.

  • K222081ID-510 iRestore EliteFreedom Laser Therapy, Inc. · 20224cite it
  • K183417iRestore Professional 282Freedom Laser Therapy, Inc. · 20193cite it
  • K151662iRestoreFreedom Laser Therapy, Inc. · 20163cite it
  • K213094ID-500 iRestore Hair Growth SystemFreedom Laser Therapy, Inc. · 20211cites it

What has FDA decided for it lately?

  • K222081ID-510 iRestore EliteFreedom Laser Therapy, Inc. · 2022
  • K213094ID-500 iRestore Hair Growth SystemFreedom Laser Therapy, Inc. · 2021
  • K183417iRestore Professional 282Freedom Laser Therapy, Inc. · 2019
  • K151662iRestoreFreedom Laser Therapy, Inc. · 2016

All 4 as Freedom Laser Therapy, Inc. →

Other applicant names beginning “Freedom”

FDA records each applicant name separately; these may or may not be the same firm.

Freedom Designs, Inc. 10Freedom Sciences, LLC 2Freedom Meditech, Inc. 1Freedom Machine, Inc. 1