Cleared Traditional

SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 (K040525) - FDA 510(k) Clearance

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

K040525 · Sontra Medical, Inc. · General & Plastic Surgery device
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Aug 2004
Decision
169d
Days
Class 2
Risk

K040525 is an FDA 510(k) clearance for the SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL .... Classified as Ultrasound, Skin Permeation (product code NRJ), Class II - Special Controls.

Submitted by Sontra Medical, Inc. (Franklin, US). The FDA issued a Cleared decision on August 17, 2004 after a review of 169 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4410 - 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. Standard predicate reliance. 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 Sontra Medical, Inc. devices

Submission Details

510(k) Number K040525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 01, 2004
Decision Date August 17, 2004
Days to Decision 169 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 115d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NRJ Ultrasound, Skin Permeation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4410
Definition Indicated For The Temporary Disruption Of The Outer Layer Of Skin For The Application Of Drugs, Etc.
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.