Cleared Traditional

K033461 - CANDELA VBEAM PULSE DYE LASER SYSTEM

K033461 is the FDA 510(k) clearance for CANDELA VBEAM PULSE DYE 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 78-day FDA review.

K033461 · Candela Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
78d
Days
Class 2
Risk

K033461 is an FDA 510(k) clearance for the CANDELA VBEAM PULSE DYE 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 January 16, 2004 after a review of 78 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 Candela Corp. devices

Submission Details

510(k) Number K033461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2003
Decision Date January 16, 2004
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
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 K033461.
APOGEE ELITE
K034030 · Cynosure, Inc. · Feb 2004
TRISTAR AESTHETIC WORKSTATION LASER
K033176 · Cynosure, Inc. · Jan 2004
CANDELA CBEAM PULSE DYE LASER SYSTEM
K033331 · Candela Corp. · Jan 2004
CANDELA SMOOTHBEAM LASER SYSTEM
K030834 · Candela Corp. · Dec 2003
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE
K033237 · Vascular Solutions, Inc. · Nov 2003
AURA ISURGICAL LASER SYSTEM & ACCESSORIES
K024206 · Laserscope · Nov 2003