PZL · Class II · 21 CFR 878.4685

FDA Product Code PZL: Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Treatment Of Diabetic Foot Ulcers

Leading manufacturers include Softwave/Trt, LLC, Tissue Regeneration Technologies and Tissue Regeneration Technologies, LLC.

8
Total
7
Cleared
212d
Avg days
2017
Since
Stable submission activity - 2 submissions in the last 2 years
Consistent review times: 206d avg (recent)

FDA 510(k) Cleared Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers Devices (Product Code PZL)

8 devices
1–8 of 8
Cleared Aug 13, 2025
DOLORCLAST Focused Shock Waves
K243279
E.M.S Electro Medical Systems S.A
General & Plastic Surgery · 301d
Cleared Jul 02, 2025
CS-Pro MED
K250779
Curative Sound Therapeutics
General & Plastic Surgery · 110d
Cleared Jul 09, 2024
OW100S
K233937
Softwave/Trt, LLC
General & Plastic Surgery · 208d
Cleared Sep 01, 2023
OW100S
K231710
Softwave/Trt, LLC
General & Plastic Surgery · 81d
Cleared Feb 21, 2021
Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
K202112
Storz Medical AG
General & Plastic Surgery · 206d
Cleared Aug 28, 2020
OrthoGold 100
K200926
Tissue Regeneration Technologies, LLC
General & Plastic Surgery · 143d
Cleared Nov 26, 2019
OrthoGold
K191961
Tissue Regeneration Technologies
General & Plastic Surgery · 126d

About Product Code PZL - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code PZL since 2017, with 7 receiving FDA clearance (average review time: 212 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - PZL Product Code

FDA review times for PZL submissions have been consistent, averaging 206 days recently vs 214 days historically.

PZL devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →