The following data is part of a premarket notification filed by Sofwave Medical Ltd. with the FDA for Sofacia System.
| Device ID | K191421 |
| 510k Number | K191421 |
| Device Name: | Sofacia System |
| Classification | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Applicant | Sofwave Medical Ltd. Beit Tavor 2 Yokneam, IL |
| Contact | Ruthie Amir |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, PA 19103 |
| Product Code | OHV |
| CFR Regulation Number | 878.4590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-28 |
| Decision Date | 2019-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290018152010 | K191421 | 000 |
| 07290018152003 | K191421 | 000 |
| 07290018152027 | K191421 | 000 |
| 07290018152065 | K191421 | 000 |
| 07290018152058 | K191421 | 000 |