Cleared Traditional

K000811 - NLITE SYSTEM, SLS MODEL NUMBER A00-1025

K000811 is an FDA 510(k) clearance for NLITE SYSTEM, manufactured by Sls Biophile , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K000811 · Sls Biophile , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
165d
Days
Class 2
Risk

K000811 is an FDA 510(k) clearance for the NLITE SYSTEM, SLS MODEL NUMBER A00-1025. 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 Sls Biophile , Ltd. (Llanelli, GB). The FDA issued a Cleared decision on August 25, 2000 after a review of 165 days - an extended review cycle.

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 - K000811

510(k) Number K000811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2000
Decision Date August 25, 2000
Days to Decision 165 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
50d slower than avg
Panel avg: 115d · This submission: 165d
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 2892
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K000811.
C02 LASER MULTIPULSE
K002032 · Asclepion-Meditec AG · Sep 2000
PROLITE VL PULSED LIGHT SYSTEM
K002072 · Medical Bio Care Sweden AB · Sep 2000
ATHOS
K001704 · Cosmos Medical Technology · Aug 2000
VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9
K000158 · Fisma, Inc. · Aug 2000
CANDELA DYNAMIC COOLING DEVICE
K001589 · Candela Corp. · Aug 2000
COOLTOUCH II
K002347 · New Star Lasers, Inc. · Aug 2000
K000811 · NLITE SYSTEM, SLS MODEL NUMBER A00-1025
Download PDF FDA Summary Sls Biophile , Ltd.