Cleared Traditional

K980559 - PEGASUS ND:YAG LASER SYSTEM

K980559 is an FDA 510(k) clearance for PEGASUS ND:YAG LASER SYSTEM, manufactured by Premier Laser Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K980559 · Premier Laser Systems, Inc. · General & Plastic Surgery device
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Aug 1998
Decision
192d
Days
Class 2
Risk

K980559 is an FDA 510(k) clearance for the PEGASUS ND:YAG 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 Premier Laser Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on August 24, 1998 after a review of 192 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 Premier Laser Systems, Inc. devices

FDA 510(k) Submission Details - K980559

510(k) Number K980559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1998
Decision Date August 24, 1998
Days to Decision 192 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 115d · This submission: 192d
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 1884
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K980559.
CYNOSURE CO3 ER:YAG LASER
K983034 · Cynosure, Inc. · Sep 1998
OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE
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NIDEK LIGHTSCAN
K982295 · Nidek, Inc. · Aug 1998
PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE)
K981627 · Xintec Corporation · Jul 1998
MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES
K980389 · Ceram Optec, Inc. · Jul 1998