Cleared Traditional

K071815 - NOVEON, MODEL LS1100-01-0968

K071815 is an FDA 510(k) clearance for NOVEON, manufactured by Nomir Medical Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K071815 · Nomir Medical Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
149d
Days
Class 2
Risk

K071815 is an FDA 510(k) clearance for the NOVEON, MODEL LS1100-01-0968. 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 Nomir Medical Technologies, Inc. (Newton, US). The FDA issued a Cleared decision on November 28, 2007 after a review of 149 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.

FDA 510(k) Submission Details - K071815

510(k) Number K071815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date November 28, 2007
Days to Decision 149 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 115d · This submission: 149d
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 2836
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K071815.
SMARTLIPO LASER
K073394 · Cynosure, Inc. · Dec 2007
MILESMAN PREMIUM
K073300 · Milesman S.L. · Dec 2007
APL MEDICAL SYSTEM
K072344 · Bios S.R.L. · Dec 2007
ERBIUM FRACTIONAL HANDPIECE
K071768 · Palomar Medical Products, Inc. · Nov 2007
ACCOLADE II LASER
K072868 · Cynosure, Inc. · Nov 2007
FRAXEL III SR LASER SYSTEM AND ACCESSORIES
K071051 · Reliant Technologies, Inc. · Nov 2007
K071815 · NOVEON, MODEL LS1100-01-0968
Download PDF FDA Summary Nomir Medical Technol…