Home / 510(k) Clearances / K200926

510(k) K200926

OrthoGold 100 by Tissue Regeneration Technologies, LLC — Product Code PZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2020
Date Received
April 7, 2020
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 Tissue Regeneration Technologies, LLC

  • K210451 — OrthoGold 100 (May 5, 2021)
  • K191961 — OrthoGold (November 26, 2019)
  • K182682 — OrthoGold 100 (December 21, 2018)
  • K062081 — LITHOGOLD (November 2, 2006)

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)
  • K231710 — OW100S (September 1, 2023)
  • K202112 — Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece (February 21, 2021)
  • K191961 — OrthoGold (November 26, 2019)
  • DEN160037 — dermaPACE System (December 28, 2017)