OW100S
FDA 510(k) clearance K233937 · decided 2024-07-09
Clearance details
- K-number
- K233937
- Device name
- OW100S
- Applicant
- Softwave/Trt, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-12-14
- Decision date
- 2024-07-09
- Days to decision
- 208 days
- Clearance type
- Traditional
- Product code
- PZL
- Device class
- 2
- Regulation number
- 878.4685
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Woodstock, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DOLORCLAST Focused Shock Waves (K243279) | E.M.S Electro Medical Systems S.A | 2025-08-13 |
| CS-Pro MED (K250779) | Curative Sound Therapeutics | 2025-07-02 |
| OW100S (K231710) | Softwave/Trt, LLC | 2023-09-01 |
| Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece (K202112) | Storz Medical AG | 2021-02-21 |
| OrthoGold 100 (K200926) | Tissue Regeneration Technologies, LLC | 2020-08-28 |
| OrthoGold (K191961) | Tissue Regeneration Technologies | 2019-11-26 |
| dermaPACE System (DEN160037) | Sanuwave, Inc. | 2017-12-28 |
Recalls involving this device
No recalls on record reference this clearance.