Cleared Traditional

K862514 - OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG S...

K862514 is the FDA 510(k) clearance for OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG S... by Laserscope. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K862514 · Laserscope · General & Plastic Surgery device
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Feb 1987
Decision
218d
Days
Class 2
Risk

K862514 is an FDA 510(k) clearance for the OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO. 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 (Santa Clara, US). The FDA issued a Cleared decision on February 4, 1987 after a review of 218 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

Submission Details

510(k) Number K862514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1986
Decision Date February 04, 1987
Days to Decision 218 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 115d · This submission: 218d
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 1170
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K862514.
MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENT
K870971 · Directed Energy, Inc. · May 1987
MODEL LS 860, CO2 LASER
K864562 · Cooper Lasersonics, Inc. · Apr 1987
MODEL LS 840, CO2 LASER
K864563 · Cooper Lasersonics, Inc. · Apr 1987
SAPPHIRE LASER BLADES (LASER BLADES) ND: YAG
K863086 · Cooper Lasersonics, Inc. · Dec 1986
CANDELA MODEL SPT-1, PULSED DYE LASER
K861179 · Candela Corp. · Nov 1986
MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG
K862408 · Directed Energy, Inc. · Oct 1986