FDA Product Code
FDA Product Code PZL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4685
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243279 | DOLORCLAST Focused Shock Waves | E.M.S Electro Medical Systems S.A | 2025-08-13 | Traditional | PDF ↗ |
| K250779 | CS-Pro MED | Curative Sound Therapeutics | 2025-07-02 | Traditional | PDF ↗ |
| K233937 | OW100S | Softwave/Trt, LLC | 2024-07-09 | Traditional | PDF ↗ |
| K231710 | OW100S | Softwave/Trt, LLC | 2023-09-01 | Traditional | PDF ↗ |
| K202112 | Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece | Storz Medical AG | 2021-02-21 | Traditional | PDF ↗ |
| K200926 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | 2020-08-28 | Traditional | PDF ↗ |
| K191961 | OrthoGold | Tissue Regeneration Technologies | 2019-11-26 | Traditional | PDF ↗ |
| DEN160037 | dermaPACE System | Sanuwave, Inc. | 2017-12-28 | Direct | — |
Product code PZL · Class II · General, Plastic Surgery. Data: openFDA.