Cleared Traditional

K014128 - CANDELA SMOOTHBEAM LASER SYSTEM

K014128 is the FDA 510(k) clearance for CANDELA SMOOTHBEAM LASER SYSTEM by Candela Corp.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K014128 · Candela Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2002
Decision
291d
Days
Class 2
Risk

K014128 is an FDA 510(k) clearance for the CANDELA SMOOTHBEAM 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 Candela Corp. (Wayland, US). The FDA issued a Cleared decision on October 4, 2002 after a review of 291 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 Candela Corp. devices

Submission Details

510(k) Number K014128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2001
Decision Date October 04, 2002
Days to Decision 291 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
176d slower than avg
Panel avg: 115d · This submission: 291d
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 986
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K014128.
MILLENNIUM MICROSURGICAL SYSTEM
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INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS
K023182 · Ethicon Endo-Surgery, Inc. · Oct 2002
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K013974 · Trimedyne, Inc. · Sep 2002
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K020021 · Laserscope · Jul 2002
CANDELA VBEAM PULSED DYE LASER SYSTEM
K021180 · Candela Corp. · Jul 2002