Cleared Traditional

K243279 - DOLORCLAST Focused Shock Waves (FDA 510(k) Clearance)

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

K243279 · E.M.S Electro Medical Systems S.A · General & Plastic Surgery device
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Aug 2025
Decision
301d
Days
Class 2
Risk

K243279 is an FDA 510(k) clearance for the DOLORCLAST Focused Shock Waves. Classified as Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers (product code PZL), Class II - Special Controls.

Submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on August 13, 2025 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all E.M.S Electro Medical Systems S.A devices

Submission Details

510(k) Number K243279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2024
Decision Date August 13, 2025
Days to Decision 301 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
187d slower than avg
Panel avg: 114d · This submission: 301d
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

Heyer Regulatory Solutions
Sheila Hemeon-Heyer

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.