The following data is part of a premarket notification filed by Soliton Inc. with the FDA for Resonic Rapid Acoustic Pulse Device.
Device ID | K212502 |
510k Number | K212502 |
Device Name: | Resonic Rapid Acoustic Pulse Device |
Classification | Powered Laser Surgical Instrument |
Applicant | Soliton Inc. 5304 Ashbrook Drive Houston, TX 77081 |
Contact | Leslie Honda |
Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, Floor 23 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 | 2021-08-09 |
Decision Date | 2021-11-05 |