Cleared Special

K141403 - LITHO DK30

K141403 is the FDA 510(k) clearance for LITHO DK30 by Quanta System Spa. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Special 510(k) pathway after a 71-day FDA review.

K141403 · Quanta System Spa · General & Plastic Surgery device
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Aug 2014
Decision
71d
Days
Class 2
Risk

K141403 is an FDA 510(k) clearance for the LITHO DK30. 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 Quanta System Spa (Solbiate Olona (Va), IT). The FDA issued a Cleared decision on August 7, 2014 after a review of 71 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K141403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2014
Decision Date August 07, 2014
Days to Decision 71 days
Submission Type Special
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
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

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 899
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K141403.
ELITE + LASER SYSTEM
K141425 · Cynosure, Inc. · Sep 2014
CALCULASE II
K140964 · KARL STORZ Endoscopy-America, Inc. · Sep 2014
LITHO
K141101 · Quanta System Spa · Aug 2014
PICOSURE WORKSTATION
K133364 · Cynosure, Inc. · Jul 2014
FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER
K140503 · Boston Scientific · Apr 2014
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
K133254 · Cynosure, Inc. · Mar 2014