Cleared Traditional

K142061 - SILHOUETTE INSTALIFT

K142061 is an FDA 510(k) clearance for SILHOUETTE INSTALIFT, manufactured by Silhouette Lift, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K142061 · Silhouette Lift, Inc. · General & Plastic Surgery device
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Apr 2015
Decision
268d
Days
Class 2
Risk

K142061 is an FDA 510(k) clearance for the SILHOUETTE INSTALIFT. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Silhouette Lift, Inc. (Irvine, US). The FDA issued a Cleared decision on April 24, 2015 after a review of 268 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - 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 Silhouette Lift, Inc. devices

FDA 510(k) Submission Details - K142061

510(k) Number K142061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2014
Decision Date April 24, 2015
Days to Decision 268 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
153d slower than avg
Panel avg: 115d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAM Device Classification - Class 2, Special Controls

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 Consultant

Health Policy Associates, Inc.
Juan Carlos Serna

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 122
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K142061.
PGA RESORBA, PGA RESOQUICK, GLYCOLON
K143584 · Resorba Medical GmbH · Nov 2015
Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron
K150717 · M/s. Meril Endo Surgery Private Limited. · Oct 2015
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
K151200 · Ethicon, Inc. · Aug 2015
PLIASURE Polyglycolide Synthetic Absorbable Suture
K142822 · Ethicon, Inc. · Mar 2015
WEGO-PGCL Absorbable Surgical Monofilament Suture
K142810 · Foosin Medical Supplies Inc., Ltd. · Nov 2014
POLYCRYL
K140039 · Aurolab · Sep 2014