Cleared Traditional

K983020 - COMPACT KTP LASER

K983020 is an FDA 510(k) clearance for COMPACT KTP LASER, manufactured by Cosmos Medical Technology. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K983020 · Cosmos Medical Technology · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
86d
Days
Class 2
Risk

K983020 is an FDA 510(k) clearance for the COMPACT KTP LASER. 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 Cosmos Medical Technology (San Diego, US). The FDA issued a Cleared decision on November 25, 1998 after a review of 86 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 Cosmos Medical Technology devices

FDA 510(k) Submission Details - K983020

510(k) Number K983020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1998
Decision Date November 25, 1998
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
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 1884
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K983020.
SURECAUT DIAMOND LASER KNIFE
K983463 · Clinicon Corp. · Dec 1998
CELL ROBOTICS' LASETTE
K981746 · Cell Robotics, Inc. · Dec 1998
MULTIPULSE CO2 LASER
K983215 · Aesculap-Meditec GmbH · Dec 1998
DORNIER MEDILA H
K983963 · Dornier Medtech America, Inc. · Nov 1998
AURORA
K981379 · Premier Laser Systems, Inc. · Nov 1998
CERALAS D LASER SYSTEM, MODEL # CERALAS D15
K983058 · Ceram Optec, Inc. · Oct 1998