Cleared Special

K010589 - MICROWAVAE DELIVERY SYSTEM #MW2000

K010589 is an FDA 510(k) clearance for MICROWAVAE DELIVERY SYSTEM #MW2000, manufactured by Mw Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MWY cleared through the Special 510(k) pathway after a 20-day FDA review.

K010589 · Mw Medical, Inc. · General & Plastic Surgery device
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Mar 2001
Decision
20d
Days
Class 2
Risk

K010589 is an FDA 510(k) clearance for the MICROWAVAE DELIVERY SYSTEM #MW2000. Classified as System, Microwave, Hair Removal (product code MWY), Class II - Special Controls.

Submitted by Mw Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on March 19, 2001 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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.

FDA 510(k) Submission Details - K010589

510(k) Number K010589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2001
Decision Date March 19, 2001
Days to Decision 20 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

MWY Device Classification - Class 2, Special Controls

Product Code MWY System, Microwave, Hair Removal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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.

K010589 · MICROWAVAE DELIVERY SYSTEM #MW2000
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