Soliton, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Soliton, Inc.” (first 2019, latest 2021), across 1 product code in 1 review panel. Median 510(k) review time under this name: 81 days. Since 2017 the median was 81 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 81 |
| 2020 | 1 | 29 |
| 2021 | 3 | 88 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Soliton, Inc. took a median 81 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 5 | 5 |
Review panels
Most recent Soliton, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212502 | Resonic Rapid Acoustic Pulse Device | GEX | 2021-11-05 | 88 |
| K210964 | Resonic Rapid Acoustic Pulse Device | GEX | 2021-04-27 | 27 |
| K201801 | Rapid Acoustic Pulse Device | GEX | 2021-01-29 | 213 |
| K200331 | Rapid Acoustic Pulse Device | GEX | 2020-03-10 | 29 |
| K190542 | Soliton Acoustic Wave Device | GEX | 2019-05-24 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Soliton, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Soliton, Inc. is the lead sponsor of 7 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04702529: Treatment of Fibrotic Scars With Rapid Acoustic Pulse (RAP) Device (Completed, started 2022-06-22)
- NCT05199506: Study to Evaluate the Safety and Effectiveness of the RAP Device for the Improvement in the Appearance of Cellulite (Completed, started 2021-05-04)
- NCT04065711: Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite (Completed, started 2019-07-20)
- NCT04016610: Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment for the Treatment of Keloid Scar (Completed, started 2019-07-09)
- NCT03981198: Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite (Completed, started 2018-07-31)
Frequently asked questions
How many FDA 510(k) clearances are listed under Soliton, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Soliton, Inc.” (first 2019, latest 2021), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Soliton, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Soliton, Inc. is 81 days. Since 2017: 81 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Soliton, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 5).
Next steps
- See all 5 Soliton, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Soliton, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.