Cleared Special

K153157 - Sonendo Gentle Wave System (FDA 510(k) Clearance)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K153157 · Sonendo, Inc. · Dental device
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Jan 2016
Decision
88d
Days
Class 2
Risk

K153157 is an FDA 510(k) clearance for the Sonendo Gentle Wave System. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Sonendo, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on January 29, 2016 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sonendo, Inc. devices

Submission Details

510(k) Number K153157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2015
Decision Date January 29, 2016
Days to Decision 88 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
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 Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

All 194
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