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)

LARES 757 WORKHORSE HIGHSPEED HANDPIECE

K-Number: K905541 · 1991-03-07

ApplicantLares Research, Inc.
Decision Date1991-03-07
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LARES 757 WORKHORSE HIGHSPEED HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Lares Research, Inc.. It received FDA 510(k) clearance on 1991-03-07 under 510(k) number K905541. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LARES 757 WORKHORSE HIGHSPEED HANDPIECE?

LARES 757 WORKHORSE HIGHSPEED HANDPIECE is a medical device that received FDA 510(k) clearance on 1991-03-07. The listed applicant is Lares Research, Inc.. The 510(k) number is K905541.

When did LARES 757 WORKHORSE HIGHSPEED HANDPIECE receive FDA 510(k) clearance?

LARES 757 WORKHORSE HIGHSPEED HANDPIECE received FDA 510(k) clearance on 1991-03-07, under 510(k) number K905541.

Who is the listed applicant for LARES 757 WORKHORSE HIGHSPEED HANDPIECE?

The FDA 510(k) record lists Lares Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LARES 757 WORKHORSE HIGHSPEED HANDPIECE?

The FDA product code for LARES 757 WORKHORSE HIGHSPEED HANDPIECE is EFB.

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 Lares Research, 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.

K031540APEX ELECTRIC HANDPIECE SYSTEMK011960LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4)K983524LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP)K961163LARES RESEARCH AS-1 LOWSPEED HANDPIECEK905543LARES APOLLO CS/CP/CK905542LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS

View all 7 devices →

Related Devices (Code: EFB)

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.

K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)Foshan Topmed Dental Co., Ltd.K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbHK240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Foshan Soco Precision Instrument Co., Ltd.

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.

↑