Cleared Traditional

K926224 - DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS

K926224 is an FDA 510(k) clearance for DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTIC..., manufactured by Diomedics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K926224 · Diomedics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
224d
Days
Class 2
Risk

K926224 is an FDA 510(k) clearance for the DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS. 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 Diomedics, Inc. (The Woodlands, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 224 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 Diomedics, Inc. devices

FDA 510(k) Submission Details - K926224

510(k) Number K926224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1992
Decision Date July 22, 1993
Days to Decision 224 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
109d slower than avg
Panel avg: 115d · This submission: 224d
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 K926224.
ACCULITE(TM) OTOPROBE
K930981 · Coherent Medical Group · Jul 1993
MODEL 5030 SUCTION HANDPIECE SYSTEM
K933017 · Sunrise Technologies, Inc. · Jul 1993
ECLIPSE 3200 FOR USE IN ORTHO SURG/ARTH APPL JOINT
K931306 · Cardiogenes · Jul 1993
UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER
K931774 · Sunrise Technologies, Inc. · Jul 1993
ZEISS LASER INDIRECT OPHTHALMOSCOPE
K924588 · Carl Zeiss, Inc. · Jul 1993
AP01 AND AP02
K925908 · Surgical Laser Technologies, Inc. · Jul 1993