Cleared Traditional

K955007 - APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM

K955007 is an FDA 510(k) clearance for APPLIED OPTRONICS MODEL AOC 5060 SURGFI..., manufactured by Applied Optronics Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K955007 · Applied Optronics Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
86d
Days
Class 2
Risk

K955007 is an FDA 510(k) clearance for the APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM. 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 Applied Optronics Corp. (South Plainfield, US). The FDA issued a Cleared decision on January 26, 1996 after a review of 86 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.

View all Applied Optronics Corp. devices

FDA 510(k) Submission Details - K955007

510(k) Number K955007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1995
Decision Date January 26, 1996
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
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 2023
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K955007.
CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE
K954934 · Candela Laser Corp. · Feb 1996
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ACCUSCAN MODEL C CO2 LASER SCANNER
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APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE
K955014 · Applied Optronics Corp. · Jan 1996
MICROQUARTZ MEDICAL TYPE B SIDE-FIRING LASER FIBER
K955861 · Microquartz Medical, Inc. · Jan 1996
INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS
K954195 · Indigo Medical, Inc. · Jan 1996