Cleared Traditional

K981143 - DILKES LASER/SUCTION CANNULAE

K981143 is an FDA 510(k) clearance for DILKES LASER/SUCTION CANNULAE, manufactured by Exmoor Plastics , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K981143 · Exmoor Plastics , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
168d
Days
Class 2
Risk

K981143 is an FDA 510(k) clearance for the DILKES LASER/SUCTION CANNULAE. 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 Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on September 14, 1998 after a review of 168 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 Exmoor Plastics , Ltd. devices

FDA 510(k) Submission Details - K981143

510(k) Number K981143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1998
Decision Date September 14, 1998
Days to Decision 168 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
53d slower than avg
Panel avg: 115d · This submission: 168d
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 1639
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K981143.
UNIPULSE CO2 SURGICAL LASER SYSTEM
K980475 · Nidek, Inc. · Dec 1998
DORNIER MEDILA H
K983963 · Dornier Medtech America, Inc. · Nov 1998
CERALAS D LASER SYSTEM, MODEL # CERALAS D15
K983058 · Ceram Optec, Inc. · Oct 1998
CYNOSURE CO3 ER:YAG LASER
K983034 · Cynosure, Inc. · Sep 1998
NIDEK LIGHTSCAN
K982295 · Nidek, Inc. · Aug 1998
PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE)
K981627 · Xintec Corporation · Jul 1998