# Soliton, Inc.

- Location (FDA's records): Houston, TX
- FDA decisions: 5 (2019–2021): 5 510(k) clearances
- Product codes: GEX (5)
- 510(k) review time since 2016: median 81 days, against 123 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 5 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cynosure, Inc.: 1 (https://510kreport.com/company/cynosure)
- On Light Sciences, Inc.: 1 (https://510kreport.com/company/on-light-sciences)

## Firms that cite its devices most
- Sofwave Medical, Ltd.: 1 (https://510kreport.com/company/sofwave-medical)
- Zeltiq Aesthetics, Inc.: 1 (https://510kreport.com/company/zeltiq-aesthetics)

## Its most-cited devices
- K201801: Rapid Acoustic Pulse Device (2021), cited by 2
- K212502: Resonic Rapid Acoustic Pulse Device (2021), cited by 1
- K210964: Resonic Rapid Acoustic Pulse Device (2021), cited by 1
- K190542: Soliton Acoustic Wave Device (2019), cited by 1

## Recent decisions
- K212502: Resonic Rapid Acoustic Pulse Device (Nov 5, 2021)
- K210964: Resonic Rapid Acoustic Pulse Device (Apr 27, 2021)
- K201801: Rapid Acoustic Pulse Device (Jan 29, 2021)
- K200331: Rapid Acoustic Pulse Device (Mar 10, 2020)
- K190542: Soliton Acoustic Wave Device (May 24, 2019)

Source page: https://510kreport.com/company/soliton