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510(k) K231710

OW100S by Softwave/Trt, LLC — Product Code PZL

K231710 is an FDA 510(k) premarket notification submitted by Softwave/Trt, LLC for the device "OW100S". The FDA issued a decision of Substantially Equivalent on September 1, 2023. The device falls under product code PZL (Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers), a Class II device regulated under 21 CFR 878.4685. Softwave/Trt, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2023
Date Received
June 12, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Device Class
Class II
Regulation Number
878.4685
Review Panel
SU
Submission Type

Treatment of diabetic foot ulcers

Other clearances by Softwave/Trt, LLC

  • K233937 — OW100S (July 9, 2024)

Other clearances for product code PZL

  • K243279 — DOLORCLAST Focused Shock Waves (August 13, 2025)
  • K250779 — CS-Pro MED (July 2, 2025)
  • K233937 — OW100S (July 9, 2024)
  • K202112 — Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece (February 21, 2021)
  • K200926 — OrthoGold 100 (August 28, 2020)
  • K191961 — OrthoGold (November 26, 2019)
  • DEN160037 — dermaPACE System (December 28, 2017)

FDA data resources