Cleared Traditional

K961705 - AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEM

K961705 is an FDA 510(k) clearance for AOC MEDICAL SYSTEM MODEL PHASE II 50 SU..., 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 183-day FDA review.

K961705 · Applied Optronics Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
183d
Days
Class 2
Risk

K961705 is an FDA 510(k) clearance for the AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL 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 November 1, 1996 after a review of 183 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 Applied Optronics Corp. devices

FDA 510(k) Submission Details - K961705

510(k) Number K961705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1996
Decision Date November 01, 1996
Days to Decision 183 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
68d slower than avg
Panel avg: 115d · This submission: 183d
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 2022
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K961705.
LIGHTSTIC MODEL 180
K962068 · Rare Earth Medical, Inc. · Nov 1996
PC LASER WITH SMART PLUG (PC EDO & DENTAL 200)
K963124 · Fisma, Inc. · Nov 1996
SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS
K963229 · Sharplan Lasers, Inc. · Nov 1996
AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM
K961710 · Applied Optronics Corp. · Nov 1996
SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER
K961935 · Sharplan Lasers, Inc. · Nov 1996
CYNOSURE PHOTOAPPEAL CO2 SURGICAL LASERS
K962993 · Cynosure, Inc. · Oct 1996