Identifiers
- 510(k) Number
- K190542 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Soliton Acoustic Wave Device is a device indicated for use as an accessory to laser tattoo removal procedures using a 1064 nm Q-Switched laser in Fitzpatrick Skin Type I-III patients. It functions by supplying saline to a handpiece that generates rapidly rising acoustic waves to assist in the tattoo removal process.
The device is supplied as a system that includes a console and handpiece, and is intended for use in clinical settings such as dermatology or plastic surgery offices. It is a reusable device, and its regulatory authorization is based on FDA 510(k) clearance under product code GEX, with the submission deemed substantially equivalent to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Soliton - Wikipedia, Soliton Acoustic Wave Device (K190542) — FDA 510(k) | Innolitics, Soliton Inc. FDA Filings - FDA.report, An analysis of solitons in surface acoustic wave devices
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190542 | Class II | Active |
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Manufacturer
- Manufacturer
- Soliton, Inc.
Sources (1)
- FDA 510(k) K190542 24 fields · synced Sep 25, 2026