Cleared Traditional

K080567 - PALOMAR ASPIRE LASER PLATFORM

K080567 is an FDA 510(k) clearance for PALOMAR ASPIRE LASER PLATFORM, manufactured by Palomar Medical Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K080567 · Palomar Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
47d
Days
Class 2
Risk

K080567 is an FDA 510(k) clearance for the PALOMAR ASPIRE LASER PLATFORM. 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 Palomar Medical Products, Inc. (Burlington, US). The FDA issued a Cleared decision on April 16, 2008 after a review of 47 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 Palomar Medical Products, Inc. devices

FDA 510(k) Submission Details - K080567

510(k) Number K080567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2008
Decision Date April 16, 2008
Days to Decision 47 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 faster than avg
Panel avg: 115d · This submission: 47d
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 1598
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K080567.
SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES
K080248 · Lutronic Corporation · Apr 2008
50W CERALAS D 1950NM DIODE LASER
K072682 · Biolitec, Inc. · Apr 2008
COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
K080525 · Cook Urological, Inc. · Apr 2008
COOLTOUCH MODELS LC215 AND COOLLIPO
K080163 · New Star Lasers, Inc. · Apr 2008
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
K073534 · Candela Corp. · Apr 2008
MODIFICATION TO PALOMAR LUX1540 HANDPIECE
K073583 · Palomar Medical Products, Inc. · Mar 2008