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)

CREAT BRAND MALAR IMPLANT

K-Number: K873434 · 1987-09-11

ApplicantAesthetech Corp.
Decision Date1987-09-11
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CREAT BRAND MALAR IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Aesthetech Corp.. It received FDA 510(k) clearance on 1987-09-11 under 510(k) number K873434. 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 CREAT BRAND MALAR IMPLANT?

CREAT BRAND MALAR IMPLANT is a medical device that received FDA 510(k) clearance on 1987-09-11. The listed applicant is Aesthetech Corp.. The 510(k) number is K873434.

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

CREAT BRAND MALAR IMPLANT received FDA 510(k) clearance on 1987-09-11, under 510(k) number K873434.

Who is the listed applicant for CREAT BRAND MALAR IMPLANT?

The FDA 510(k) record lists Aesthetech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREAT BRAND MALAR IMPLANT?

The FDA product code for CREAT BRAND 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 Aesthetech Corp. 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.

K873940CREAT BRAND O-RISE GENERAL ASPIRATORK853189CREAT BRAND I/A PACK CREAT BRAND PHACO PACKK843678CREAT BRAND SKIN EXPANDERK841283DISPOSABLE SUCTION TUBING SETK812210CREAT BRAND WAGNER CHIN IMPLANT

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.

K021419AART MALAR IMPLANTAesthetic and Reconstructive Technologies, Inc.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, LLC

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.

↑