Cleared Special

K123980 - SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES

K123980 is an FDA 510(k) clearance for SONICONE PLUS ULTRASOUND WOUND CARE SYS..., manufactured by Misonix, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NRB cleared through the Special 510(k) pathway after a 69-day FDA review.

K123980 · Misonix, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
69d
Days
Class 2
Risk

K123980 is an FDA 510(k) clearance for the SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES. Classified as Wound Cleaner, Ultrasound (product code NRB), Class II - Special Controls.

Submitted by Misonix, Inc. (Farmingdale, US). The FDA issued a Cleared decision on March 5, 2013 after a review of 69 days - a notably fast clearance 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. 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 Misonix, Inc. devices

FDA 510(k) Submission Details - K123980

510(k) Number K123980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2012
Decision Date March 05, 2013
Days to Decision 69 days
Submission Type Special
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
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

NRB Device Classification - Class 2, Special Controls

Product Code NRB Wound Cleaner, Ultrasound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4410
Definition The Ultrasound Wound Cleaner/mild Debridement System Is A Device That Delivers A Cleaning Fluid To The Wound That Is Pulsed Using Low Power Ultrasound Radiation. The Device Is Intended To Clean And Mildly Debride Wounds. The Ultrasound Generator Must Deliver 1.0 Mw/cm2 Or Less Energy To The Wound
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 Peers - NRB Wound Cleaner, Ultrasound

All 8
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