Cleared Traditional

K162191 - NAVILAS Laser System

K162191 is an FDA 510(k) clearance for NAVILAS Laser System, manufactured by Od-Os GmbH. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K162191 · Od-Os GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
110d
Days
Class 2
Risk

K162191 is an FDA 510(k) clearance for the NAVILAS Laser System. 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 Od-Os GmbH (Teltow, DE). The FDA issued a Cleared decision on November 22, 2016 after a review of 110 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 Od-Os GmbH devices

FDA 510(k) Submission Details - K162191

510(k) Number K162191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2016
Decision Date November 22, 2016
Days to Decision 110 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
5d faster than avg
Panel avg: 115d · This submission: 110d
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 1537
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K162191.
Smart Laser Indirect Ophthalmoscope (LIO)
K162837 · Lumenis, Ltd. · Feb 2017
Discovery Pico Family
K163222 · Quanta System Spa · Dec 2016
Litho
K163009 · Quanta System Spa · Dec 2016
VenaCure EVLT NeverTouch Procedure Kit
K162914 · AngioDynamics, Inc. · Nov 2016
Cutera enlighten III Laser System
K160488 · Cutera, Inc. · Oct 2016
Sterling 5W Diode Laser
K160413 · CAO Group, Inc. · Sep 2016