Cleared Traditional

K943988 - IMPLANTECH NASAL LABIAL IMPLANT

K943988 is an FDA 510(k) clearance for IMPLANTECH NASAL LABIAL IMPLANT, manufactured by Implantech Associates, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LZK cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K943988 · Implantech Associates, Inc. · General & Plastic Surgery device
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Jan 1995
Decision
164d
Days
Class 2
Risk

K943988 is an FDA 510(k) clearance for the IMPLANTECH NASAL LABIAL IMPLANT. Classified as Implant, Malar (product code LZK), Class II - Special Controls.

Submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on January 27, 1995 after a review of 164 days - an extended review 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: 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 Implantech Associates, Inc. devices

FDA 510(k) Submission Details - K943988

510(k) Number K943988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1994
Decision Date January 27, 1995
Days to Decision 164 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
49d slower than avg
Panel avg: 115d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZK Device Classification - Class 2, Special Controls

Product Code LZK Implant, Malar
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 - LZK Implant, Malar

All 32
Devices cleared under the same product code (LZK) and FDA review panel - the closest regulatory comparables to K943988.
MEDIAL MALAR IMPLANT
K961080 · Rand Scientific Corp. · Apr 1996
PERMAMESH-D HYDROXYLAPATITE MATRIX
K960354 · Ceramed Corp. · Mar 1996
PERMAMESH HYDROXYLAPATITE MATRIX
K960362 · Ceramed Corp. · Mar 1996
MENISCUS CHIN IMPLANT
K944164 · Spectrum Designs, Inc. · Nov 1994
SILHOUETTE MALAR IMPLANT
K944165 · Spectrum Designs, Inc. · Nov 1994
DORSAL COLUMELLA IMPLANT
K944166 · Spectrum Designs, Inc. · Nov 1994