510(k) Report

FDA applicant

Soliton, Inc.

Houston, TX5 decisions2019–20210 recalls

FDA records 5 decisions for Soliton, Inc. (Houston, TX) from 2019 to 2021: 5 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 81 days from receipt to decision, against 123 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

3in 2021

2019: 12020: 12021: 3
2019high 3 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Soliton, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Soliton, 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?

  • GEXPowered Laser Surgical Instrument5decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 81 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 123 days; 4 of its 5 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 5 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.

  • K201801Rapid Acoustic Pulse DeviceSoliton, Inc. · 20212cite it
  • K212502Resonic Rapid Acoustic Pulse DeviceSoliton, Inc. · 20211cites it
  • K210964Resonic Rapid Acoustic Pulse DeviceSoliton, Inc. · 20211cites it
  • K190542Soliton Acoustic Wave DeviceSoliton, Inc. · 20191cites it

What has FDA decided for it lately?

  • K212502Resonic Rapid Acoustic Pulse DeviceSoliton, Inc. · 2021
  • K210964Resonic Rapid Acoustic Pulse DeviceSoliton, Inc. · 2021
  • K201801Rapid Acoustic Pulse DeviceSoliton, Inc. · 2021
  • K200331Rapid Acoustic Pulse DeviceSoliton, Inc. · 2020
  • K190542Soliton Acoustic Wave DeviceSoliton, Inc. · 2019

All 5 as Soliton, Inc. →