Cleared Traditional

K991456 - MICROWAVE DELIVERY SYSTEM, MODEL MMC-300

K991456 is an FDA 510(k) clearance for MICROWAVE DELIVERY SYSTEM, manufactured by Microwave Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MWY cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K991456 · Microwave Medical, Inc. · General & Plastic Surgery device
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Oct 1999
Decision
182d
Days
Class 2
Risk

K991456 is an FDA 510(k) clearance for the MICROWAVE DELIVERY SYSTEM, MODEL MMC-300. Classified as System, Microwave, Hair Removal (product code MWY), Class II - Special Controls.

Submitted by Microwave Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on October 25, 1999 after a review of 182 days - an extended review 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. 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 Microwave Medical, Inc. devices

FDA 510(k) Submission Details - K991456

510(k) Number K991456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1999
Decision Date October 25, 1999
Days to Decision 182 days
Submission Type Traditional
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
67d slower than avg
Panel avg: 115d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.