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)

AR1000 ULTRASONIC WOUND THERAPY SYSTEM

K-Number: K062544 · 2007-01-03

ApplicantArobella Medical, LLC
Decision Date2007-01-03
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

AR1000 ULTRASONIC WOUND THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arobella Medical, LLC. It received FDA 510(k) clearance on 2007-01-03 under 510(k) number K062544. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AR1000 ULTRASONIC WOUND THERAPY SYSTEM?

AR1000 ULTRASONIC WOUND THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-01-03. The listed applicant is Arobella Medical, LLC. The 510(k) number is K062544.

When did AR1000 ULTRASONIC WOUND THERAPY SYSTEM receive FDA 510(k) clearance?

AR1000 ULTRASONIC WOUND THERAPY SYSTEM received FDA 510(k) clearance on 2007-01-03, under 510(k) number K062544.

Who is the listed applicant for AR1000 ULTRASONIC WOUND THERAPY SYSTEM?

The FDA 510(k) record lists Arobella Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AR1000 ULTRASONIC WOUND THERAPY SYSTEM?

The FDA product code for AR1000 ULTRASONIC WOUND THERAPY SYSTEM is LFL.

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 Arobella Medical, LLC 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.

K091038AS 1000 ULTRASOUND WOUND THERAPY SYSTEM

Related Devices (Code: LFL)

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.

K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLCK251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences CorporationK242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)Shanghai Saints Sages Surgical Co., Ltd.K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)Stryker InstrumentsK241700Tenex 2nd Generation SystemTrice Medical, Inc.K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation

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.

↑