Cleared Traditional

K231710 - OW100S (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231710 · Softwave/Trt, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
81d
Days
Class 2
Risk

K231710 is an FDA 510(k) clearance for the OW100S. Classified as Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers (product code PZL), Class II - Special Controls.

Submitted by Softwave/Trt, LLC (Woodstock, US). The FDA issued a Cleared decision on September 1, 2023 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4685 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Softwave/Trt, LLC devices

Submission Details

510(k) Number K231710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2023
Decision Date September 01, 2023
Days to Decision 81 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 114d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4685
Definition Treatment Of Diabetic Foot Ulcers
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

M Squared Associates/A Ppg Company
Cherita James

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

All 7
Devices cleared under the same product code (PZL) and FDA review panel - the closest regulatory comparables to K231710.
DOLORCLAST Focused Shock Waves
K243279 · E.M.S Electro Medical Systems S.A · Aug 2025
CS-Pro MED
K250779 · Curative Sound Therapeutics · Jul 2025
OW100S
K233937 · Softwave/Trt, LLC · Jul 2024
Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
K202112 · Storz Medical AG · Feb 2021