Cleared Traditional

K083102 - REFINE LIFT SYSTEM

K083102 is an FDA 510(k) clearance for REFINE LIFT SYSTEM, manufactured by Alure Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K083102 · Alure Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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May 2009
Decision
203d
Days
Class 2
Risk

K083102 is an FDA 510(k) clearance for the REFINE LIFT SYSTEM. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Alure Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 11, 2009 after a review of 203 days - an extended review 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. 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 Alure Medical, Inc. devices

FDA 510(k) Submission Details - K083102

510(k) Number K083102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2008
Decision Date May 11, 2009
Days to Decision 203 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 115d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

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 220
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K083102.
C-QUR V -PATCH MESH
K090909 · Atrium Medical Corp. · Jun 2009
PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
K090934 · American Medical Systems, Inc. · Jun 2009
ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
K090489 · Kci USA, Inc. · May 2009
PARIETEX MONOFILAMENT POLYESTER MESH
K090858 · Sofradim Production · May 2009
GORE BIO-A FISTULA PLUG
K083266 · W.L. Gore & Associates, Inc. · Mar 2009
NUVASIVE SURGICAL MESH SYSTEM
K081377 · Nuvasive, Inc. · Jan 2009