Cleared Traditional

K964818 - ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION)

K964818 is an FDA 510(k) clearance for ORION SERIES SURGICAL LASER SYSTEM (Q-S..., manufactured by Laserscope. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K964818 · Laserscope · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
200d
Days
Class 2
Risk

K964818 is an FDA 510(k) clearance for the ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION). 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 Laserscope (San Jose, US). The FDA issued a Cleared decision on June 17, 1997 after a review of 200 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 Laserscope devices

FDA 510(k) Submission Details - K964818

510(k) Number K964818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1996
Decision Date June 17, 1997
Days to Decision 200 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
85d slower than avg
Panel avg: 115d · This submission: 200d
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 2239
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K964818.
EPILIGHT HAIR REMOVAL SYSTEM
K963249 · Esc Medical Systems , Ltd. · Jul 1997
LASERSCOPE MICROBEAM IV MICROMANIPULATOR
K971250 · Laserscope · Jun 1997
LASEAWAY LONG PULSE AND Q-SWITCHED RUBY LASER SYSTEM
K971193 · Polytec Pi, Inc. · Jun 1997
SOFTSCAN
K971024 · Sahar Technologies, Inc. · Jun 1997
DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES
K971065 · Xintec Corporation · Jun 1997
CB ERBIUM/2.94(TM) ER:YAG LASER
K970934 · Continuum Biomedical, Inc. · Jun 1997