Cleared Traditional

K934233 - ZARA ZONE IV MALAR IMPLANT MODIFICATION

K934233 is an FDA 510(k) clearance for ZARA ZONE IV MALAR IMPLANT MODIFICATION, manufactured by Byron Medical. The device is a Class 2 General & Plastic Surgery device with product code LZK cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K934233 · Byron Medical · General & Plastic Surgery device
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Feb 1994
Decision
157d
Days
Class 2
Risk

K934233 is an FDA 510(k) clearance for the ZARA ZONE IV MALAR IMPLANT MODIFICATION. Classified as Implant, Malar (product code LZK), Class II - Special Controls.

Submitted by Byron Medical (Tucson, US). The FDA issued a Cleared decision on February 3, 1994 after a review of 157 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 Byron Medical devices

FDA 510(k) Submission Details - K934233

510(k) Number K934233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1993
Decision Date February 03, 1994
Days to Decision 157 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 115d · This submission: 157d
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 15
Devices cleared under the same product code (LZK) and FDA review panel - the closest regulatory comparables to K934233.
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
K961511 · Lifecore Biomedical, Inc. · Jun 1996
SAM FACIAL IMPLANT
K961210 · W.L. Gore & Associates, Inc. · Jun 1996
IMPLANTECH NASAL LABIAL IMPLANT
K943988 · Implantech Associates, Inc. · Jan 1995
FLOWERS MEDIAL MALAR IMPLANT
K921582 · Implantech Associates, Inc. · May 1992
ZARA ZONE IV MALAR IMPLANT
K914016 · Byron Medical · Dec 1991
TRAPEZOIDAL MALAR IMPLANT
K911513 · Implantech Associates, Inc. · Jul 1991