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Silhouette Malar Implant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K944165

by Spectrum Designs, Inc.

Identifiers

510(k) Number
K944165 FDA 510(k)
FDA Product Code
LZK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.3550 FDA 510(k)
Regulation Number
878.3550 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an implant, malar, as defined in the device name and specifications. It is a malar implant intended for use in plastic surgery procedures.

The device received FDA 510(k) clearance K944165 on November 4, 1994, and is classified as a Class II device. It is manufactured by Spectrum Designs, Inc. and is supplied as a sterile, single-use implant for malar augmentation in general and plastic surgery settings.

Frequently asked questions

What is the SILHOUETTE MALAR IMPLANT used for?

The SILHOUETTE MALAR IMPLANT is intended for use in plastic surgery procedures, specifically for malar augmentation. It is designed to enhance the cheekbone area in general and plastic surgery settings as a sterile, single-use implant.

How is the SILHOUETTE MALAR IMPLANT supplied and is it reusable?

The device is supplied as a sterile, single-use implant. It is not intended for reuse; each implant is designed for one-time use only to maintain sterility and patient safety during malar augmentation procedures.

What regulatory clearance does the SILHOUETTE MALAR IMPLANT have?

The SILHOUETTE MALAR IMPLANT received FDA 510(k) clearance under number K944165 on November 4, 1994. It is classified as a Class II medical device and was determined to be substantially equivalent to a predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SILHOUETTE MALAR IMPLANT (K944165) — FDA 510 (k) | Innolitics, K944165 FDA 510 (k) - SILHOUETTE MALAR IMPLANT, Silhouette Studio | Silhouette Europa, PDF K944165 SILHOUETTE MALAR IMPLANT - 510kdatabase.net, SILHOUETTE MALAR IMPLANT 510(k) K944165 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spectrum Designs, Inc.

Sources (1)

  • FDA 510(k) K944165 24 fields · synced Oct 1, 2026