Cleared Traditional

CS-Pro MED

K250779 · Curative Sound Therapeutics · General & Plastic Surgery

Jul 2025

Decision

110d

Days

Class 2

Risk

About This 510(k) Submission

K250779 is an FDA 510(k) clearance for the CS-Pro MED, a Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers (Class II — Special Controls, product code PZL), submitted by Curative Sound Therapeutics (Carmel, US). The FDA issued a Cleared decision on July 2, 2025, 110 days after receiving the submission on March 14, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4685.

Submission Details

510(k) Number	K250779 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2025
Decision Date	July 02, 2025
Days to Decision	110 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	PZL — Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4685
Definition	Treatment Of Diabetic Foot Ulcers