Cleared Traditional

K914520 - DIOMED 25 SURGICAL DIODE LASER

K914520 is the FDA 510(k) clearance for DIOMED 25 SURGICAL DIODE LASER by Dio-Med Corp.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 470-day FDA review.

K914520 · Dio-Med Corp. · General & Plastic Surgery device
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Jan 1993
Decision
470d
Days
Class 2
Risk

K914520 is an FDA 510(k) clearance for the DIOMED 25 SURGICAL DIODE LASER, UROLOGY APPLICAT. 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 Dio-Med Corp. (Cambridge Cb4 4ws England, GB). The FDA issued a Cleared decision on January 22, 1993 after a review of 470 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Dio-Med Corp. devices

Submission Details

510(k) Number K914520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1991
Decision Date January 22, 1993
Days to Decision 470 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
355d slower than avg
Panel avg: 115d · This submission: 470d
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 1400
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K914520.
ORION YAG LASER SYSTEM EAR, NOSE, & THROAT APPLIC.
K910825 · Pfizer Laser Systems · Feb 1993
ENDOSTATS, MICROSTATS, ACCUSTATS
K924644 · Laserscope · Feb 1993
DORNIER FIBERTOME 100 WATT SURGICAL LASER
K921549 · Dornier Medtech America, Inc. · Feb 1993
CANDELA LASSER SYSTEMS MODIFIED
K924158 · Candela Laser Corp. · Jan 1993
EXCEL TRIPULSE MODEL3000
K924729 · Excel Tech. , Ltd. · Jan 1993
SHARPULSE
K923855 · Sharplan Lasers, Inc. · Dec 1992