Cleared Traditional

K082101 - LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE

K082101 is an FDA 510(k) clearance for LS FAMILY OF CO2 LASERS WITH SCANNING H..., manufactured by Sandstone Medical Technologies, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K082101 · Sandstone Medical Technologies, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
103d
Days
Class 2
Risk

K082101 is an FDA 510(k) clearance for the LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE. 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 Sandstone Medical Technologies, LLC (Birmingham, US). The FDA issued a Cleared decision on November 5, 2008 after a review of 103 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 Sandstone Medical Technologies, LLC devices

FDA 510(k) Submission Details - K082101

510(k) Number K082101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2008
Decision Date November 05, 2008
Days to Decision 103 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
12d faster than avg
Panel avg: 115d · This submission: 103d
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 1750
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K082101.
15W CERALAS D 1470NM DIODE LASER, MODEL D1470
K082225 · Biolitec, Inc. · Dec 2008
ULTRAWAVE III EX 1320
K083207 · Quanta System Spa · Nov 2008
EZLASE 10W
K083069 · Biolase Technology, Inc. · Nov 2008
CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980
K082263 · Biolitec, Inc. · Oct 2008
PROFILE MULTI-PLATFORM SYSTEM
K081352 · Sciton, Inc · Oct 2008
STRAIGHT FIRE HOLMIUM LASER FIBER
K082928 · Boston Scientific Corp · Oct 2008