Cleared Special

K070993 - TOPAS SYSTEM

K070993 is the FDA 510(k) clearance for TOPAS SYSTEM by American Medical Systems, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Special 510(k) pathway after a 30-day FDA review.

K070993 · American Medical Systems, Inc. · General & Plastic Surgery device
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May 2007
Decision
30d
Days
Class 2
Risk

K070993 is an FDA 510(k) clearance for the TOPAS SYSTEM. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on May 9, 2007 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - 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 American Medical Systems, Inc. devices

Submission Details

510(k) Number K070993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2007
Decision Date May 09, 2007
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - FTL Mesh, Surgical, Polymeric

All 185
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K070993.
IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
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ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
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ULTRAPRO PLUG
K070224 · Ethicon, Inc. · Apr 2007
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
K070644 · W.L. Gore & Associates, Inc. · Apr 2007
ATRIUM PROLITE ULTRA S MESH
K070192 · Atrium Medical Corp. · Mar 2007