Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AART MALAR IMPLANT

K-Number: K021419 · 2002-07-02

ApplicantAesthetic and Reconstructive Technologies, Inc.
Decision Date2002-07-02
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AART MALAR IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Aesthetic and Reconstructive Technologies, Inc.. It received FDA 510(k) clearance on 2002-07-02 under 510(k) number K021419. The device is classified under product code LZK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AART MALAR IMPLANT?

AART MALAR IMPLANT is a medical device that received FDA 510(k) clearance on 2002-07-02. The listed applicant is Aesthetic and Reconstructive Technologies, Inc.. The 510(k) number is K021419.

When did AART MALAR IMPLANT receive FDA 510(k) clearance?

AART MALAR IMPLANT received FDA 510(k) clearance on 2002-07-02, under 510(k) number K021419.

Who is the listed applicant for AART MALAR IMPLANT?

The FDA 510(k) record lists Aesthetic and Reconstructive Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AART MALAR IMPLANT?

The FDA product code for AART MALAR IMPLANT is LZK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Aesthetic and Reconstructive Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K023678DIMISIL SCAR GELK022306AART SILICONE TUBINGK022511AART CALF IMPLANTK022223AART SILICONE SHEETINGK021839AART GLUTEAL IMPLANTK021820AART SILICONE CARVING BLOCK

View all 10 devices →

Related Devices (Code: LZK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K002886IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)Implantech Associates, Inc.K992240PILLAR MALAR IMPLANTPillar Surgical, Inc.K983756SURGIFORM ANATOMICAL MALARSurgical Technology Laboratories, Inc.K982763SEARE BIOMEDICAL MALAR IMPLANTSSeare Biomedical Corp.K981835SILIMED MALAR IMPLANTSilimed, LLCK980140SPECTRUM DESIGNS MEDIAL MALAR IMPLANTSpectrum Designs, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑