The following data is part of a premarket notification filed by Soliton Inc. with the FDA for Soliton Acoustic Wave Device.
| Device ID | K190542 |
| 510k Number | K190542 |
| Device Name: | Soliton Acoustic Wave Device |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Soliton Inc. 5304 Ashbrook Drive Houston, TX 77081 |
| Contact | Leslie Honda |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, PA 19103 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-04 |
| Decision Date | 2019-05-24 |