Cleared Traditional

K153564 - PURE CRYOGEN

K153564 is an FDA 510(k) clearance for PURE CRYOGEN, manufactured by Air Liquide Healthcare America Corporation. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K153564 · Air Liquide Healthcare America Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
106d
Days
Class 2
Risk

K153564 is an FDA 510(k) clearance for the PURE CRYOGEN. 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 Air Liquide Healthcare America Corporation (Houston, US). The FDA issued a Cleared decision on March 29, 2016 after a review of 106 days - within the typical 510(k) review window.

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 Air Liquide Healthcare America Corporation devices

FDA 510(k) Submission Details - K153564

510(k) Number K153564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2015
Decision Date March 29, 2016
Days to Decision 106 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 115d · This submission: 106d
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 1680
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K153564.
Medilas H Laser Fibers
K161771 · Dornier Medtech America, Inc. · Jul 2016
PicoSure Workstation
K160480 · Cynosure, Inc. · May 2016
EVO platform
K160368 · Quanta System Spa · Apr 2016
Quanta System Surgical Laser fibers
K160513 · Quanta System Spa · Mar 2016
Family of CoolGlide Aesthetic Lasers
K153671 · Cutera, Inc. · Mar 2016
Quanta Forte
K152714 · Quanta System Spa · Dec 2015