Cleared Traditional

K071295 - 100W CERALAS D 980NM DIODE LASER

K071295 is the FDA 510(k) clearance for 100W CERALAS D 980NM 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 8-day FDA review.

K071295 · Biolitec, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
8d
Days
Class 2
Risk

K071295 is an FDA 510(k) clearance for the 100W CERALAS D 980NM 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 May 16, 2007 after a review of 8 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 Biolitec, Inc. devices

Submission Details

510(k) Number K071295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2007
Decision Date May 16, 2007
Days to Decision 8 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
107d faster than avg
Panel avg: 115d · This submission: 8d
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 K071295.
MOSAIC LASER SYSTEM
K070392 · Lutronic Corporation · Jul 2007
ULTRAWAVE II EX 1320
K070805 · Quanta System Spa · Jul 2007
MEDILAS D FAMILY LASERS
K070536 · Dornier Medtech America, Inc. · May 2007
CUTERA ER:YSGG LASER HANDPIECE
K063867 · Cutera, Inc. · Mar 2007
CUTERA ER:YAG LASER HANDPIECE
K070138 · Cutera, Inc. · Mar 2007
GENESIS DIODE LASER
K062258 · Ivoclar Vivadent, Inc. · Mar 2007