Cleared Traditional

K043486 - PASCAL PHOTOCOAGULATOR

K043486 is the FDA 510(k) clearance for PASCAL PHOTOCOAGULATOR by Topcon Medical Laser Systems, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K043486 · Topcon Medical Laser Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
76d
Days
Class 2
Risk

K043486 is an FDA 510(k) clearance for the PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01. 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 Topcon Medical Laser Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on March 3, 2005 after a review of 76 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Topcon Medical Laser Systems, Inc. devices

Submission Details

510(k) Number K043486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2004
Decision Date March 03, 2005
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 882
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K043486.
ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050
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CYNERGY LASER
K043429 · Cynosure, Inc. · Jan 2005
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
K042785 · Nidek, Inc. · Dec 2004
OMNIPULSE MINI, MODEL 2120
K043012 · Trimedyne, Inc. · Nov 2004