Cleared Traditional

K983463 - SURECAUT DIAMOND LASER KNIFE

K983463 is an FDA 510(k) clearance for SURECAUT DIAMOND LASER KNIFE, manufactured by Clinicon Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K983463 · Clinicon Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
71d
Days
Class 2
Risk

K983463 is an FDA 510(k) clearance for the SURECAUT DIAMOND LASER KNIFE. 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 Clinicon Corp. (Carlsbad, US). The FDA issued a Cleared decision on December 11, 1998 after a review of 71 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.

FDA 510(k) Submission Details - K983463

510(k) Number K983463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1998
Decision Date December 11, 1998
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
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 2732
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K983463.
UNIPULSE CO2 SURGICAL LASER SYSTEM
K980475 · Nidek, Inc. · Dec 1998
LASEAWAY ALEXANDRITE LASER SYSTEM
K982316 · Silver Creek, Inc. · Dec 1998
ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM
K983543 · Argus Photonics Group · Dec 1998
CELL ROBOTICS' LASETTE
K981746 · Cell Robotics, Inc. · Dec 1998
MULTIPULSE CO2 LASER
K983215 · Aesculap-Meditec GmbH · Dec 1998
COMPACT KTP LASER
K983020 · Cosmos Medical Technology · Nov 1998
K983463 · SURECAUT DIAMOND LASER KNIFE
Download PDF FDA Summary Clinicon Corp.