Cleared Traditional

K072682 - 50W CERALAS D 1950NM DIODE LASER

K072682 is the FDA 510(k) clearance for 50W CERALAS D 1950NM DIODE LASER by Biolitec, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K072682 · Biolitec, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 2008
Decision
210d
Days
Class 2
Risk

K072682 is an FDA 510(k) clearance for the 50W CERALAS D 1950NM DIODE LASER. 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 Biolitec, Inc. (Washington, US). The FDA issued a Cleared decision on April 18, 2008 after a review of 210 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 Biolitec, Inc. devices

Submission Details

510(k) Number K072682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2007
Decision Date April 18, 2008
Days to Decision 210 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
95d slower than avg
Panel avg: 115d · This submission: 210d
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 1399
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K072682.
SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER
K081181 · Cynosure, Inc. · May 2008
ELIPO
K073715 · Syneron Medical, Ltd. · Apr 2008
SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES
K080248 · Lutronic Corporation · 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