Cleared Traditional

K871074 - OMEGA EXTENDED MALAR AND OMEGA CONTOURE...

K871074 is an FDA 510(k) clearance for OMEGA EXTENDED MALAR AND OMEGA CONTOURE..., manufactured by Omega Silicone, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FWP cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K871074 · Omega Silicone, Inc. · General & Plastic Surgery device
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Apr 1987
Decision
23d
Days
Class 2
Risk

K871074 is an FDA 510(k) clearance for the OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Omega Silicone, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on April 10, 1987 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3550 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Omega Silicone, Inc. devices

FDA 510(k) Submission Details - K871074

510(k) Number K871074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1987
Decision Date April 10, 1987
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FWP Device Classification - Class 2, Special Controls

Product Code FWP Prosthesis, Chin, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3550
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 - FWP Prosthesis, Chin, Internal

All 29
Devices cleared under the same product code (FWP) and FDA review panel - the closest regulatory comparables to K871074.
EXTENDED CHIN IMPLANT STYLE II
K902825 · Implantech Associates, Inc. · Aug 1990
ANATOMICAL MANDIBULAR IMPLANT STYLE I
K902826 · Implantech Associates, Inc. · Aug 1990
ANATOMICAL MANDIBULAR IMPLANT STYLE II
K902827 · Implantech Associates, Inc. · Aug 1990
BYRON SILICONE CHIN IMPLANTS
K863397 · Byron Medical · Sep 1986