Cleared Traditional

K931776 - DIOMED 25 25W SURGICAL DIODE LASER

K931776 is the FDA 510(k) clearance for DIOMED 25 25W 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 193-day FDA review.

K931776 · Dio-Med Corp. · General & Plastic Surgery device
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Oct 1993
Decision
193d
Days
Class 2
Risk

K931776 is an FDA 510(k) clearance for the DIOMED 25 25W SURGICAL DIODE 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 Dio-Med Corp. (North Attleboro, US). The FDA issued a Cleared decision on October 19, 1993 after a review of 193 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 Dio-Med Corp. devices

Submission Details

510(k) Number K931776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1993
Decision Date October 19, 1993
Days to Decision 193 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
78d slower than avg
Panel avg: 115d · This submission: 193d
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 K931776.
ORION YAG LASER SYSTEM OPHTHALMOLOGY
K910826 · Pfizer Laser Systems · Nov 1993
ORION
K911288 · Pfizer Laser Systems · Nov 1993
SHARPLAN SHARPLASE LATERAL ND:YAG FIBER
K930582 · Sharplan Lasers, Inc. · Nov 1993
ZEISS OPMILAS 144 SURGICAL LASERS
K933322 · Carl Zeiss, Inc. · Oct 1993
VISIDISC KITS, SPINESCOPE
K924720 · Laserscope · Oct 1993
SHARPLASE SHORT FIBER ND:YAG DELIVERY SYSTEM
K931978 · Sharplan Lasers, Inc. · Sep 1993