Cleared Traditional

K091800 - LIPOEZE LASER ASSISTED ASPIRATION CANNULA

K091800 is an FDA 510(k) clearance for LIPOEZE LASER ASSISTED ASPIRATION CANNULA, manufactured by Curve Medical. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K091800 · Curve Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
98d
Days
Class 2
Risk

K091800 is an FDA 510(k) clearance for the LIPOEZE LASER ASSISTED ASPIRATION CANNULA. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Curve Medical (Ashland, US). The FDA issued a Cleared decision on September 23, 2009 after a review of 98 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Curve Medical devices

FDA 510(k) Submission Details - K091800

510(k) Number K091800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2009
Decision Date September 23, 2009
Days to Decision 98 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEX Device Classification - Class 2, Special Controls

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 1849
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K091800.
GREENLIGHT XPS LASER SYSTEM
K092735 · American Medical Systems, Inc. · Nov 2009
ECO2 LASER SYSTEM
K091115 · Lutronic Corporation · Oct 2009
WATERLASE MD
K083927 · Biolase Technology, Inc. · Oct 2009
CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH
K091537 · Cynosure, Inc. · Sep 2009
SPECTRA SP II, SPECTRA DENTA II
K091320 · Lutronic Corporation · Aug 2009
WATERLASE C100, MODEL 7100104
K091922 · Biolase Technology, Inc. · Jul 2009