Implantech Midface-Submalar Le Fort Implant

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K942420 ↗

FDA Product Code

LZK

Device Class

Class II

Regulation

21 CFR Part 878.3550

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT used for?

  This device is a malar implant designed for midface-submalar Le Fort applications, specifically intended for use in facial reconstruction or augmentation procedures within general and plastic surgery settings, as indicated in its FDA 510(k) clearance documentation.

• How was the IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT cleared for market?

  The device obtained FDA 510(k) clearance through a traditional submission process, identified as K942420, which was granted on August 8, 1994, after being determined substantially equivalent to a predicate device under product code LZK and regulation 878.3550.

• Is the IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT a Class II device?

  Yes, the device is classified as Class II by the FDA, as confirmed in its 510(k) clearance documentation, which places it in a moderate-risk category requiring special controls to ensure safety and effectiveness for its intended use in facial reconstruction or augmentation.