Cleared Traditional

K992597 - LORAD LT-100 LASER TREATMENT SYSTEM

K992597 is an FDA 510(k) clearance for LORAD LT-100 LASER TREATMENT SYSTEM, manufactured by Focus Medical, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K992597 · Focus Medical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
265d
Days
Class 2
Risk

K992597 is an FDA 510(k) clearance for the LORAD LT-100 LASER TREATMENT 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 Focus Medical, LLC (Ridgefield, US). The FDA issued a Cleared decision on April 24, 2000 after a review of 265 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.

View all Focus Medical, LLC devices

FDA 510(k) Submission Details - K992597

510(k) Number K992597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1999
Decision Date April 24, 2000
Days to Decision 265 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
150d slower than avg
Panel avg: 115d · This submission: 265d
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 1681
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K992597.
CANDELA GENTLELASE GL DERMATOLOGICAL LASER
K994260 · Candela Corp. · May 2000
PALOMAR SLP 2000
K994225 · Palomar Medical Technologies, Inc. · May 2000
KAVO K.E.Y. LASER 1242
K000805 · Kavo America · May 2000
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
K000106 · Fotona D.D. · Apr 2000
CYNOSURE PHOTOGENICA VLS-STAR
K000490 · Cynosure, Inc. · Mar 2000
COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER
K000498 · Lumenis, Inc. · Mar 2000