Cleared Traditional

K010928 - PROLITE VL PULSED LIGHT SYSTEM

K010928 is an FDA 510(k) clearance for PROLITE VL PULSED LIGHT SYSTEM, manufactured by Medical Bio Care Sweden AB. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K010928 · Medical Bio Care Sweden AB · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
83d
Days
Class 2
Risk

K010928 is an FDA 510(k) clearance for the PROLITE VL PULSED LIGHT 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 Medical Bio Care Sweden AB (Woodland, US). The FDA issued a Cleared decision on June 19, 2001 after a review of 83 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.

FDA 510(k) Submission Details - K010928

510(k) Number K010928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2001
Decision Date June 19, 2001
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEX Device Classification - Class 2, Special Controls

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 2890
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K010928.
WATERLASE, MILLENNIUM
K011041 · Biolase Technology, Inc. · Jul 2001
MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER
K011677 · Continuum Electro-Optics, Inc. · Jun 2001
MODIFICATION TO PROLITE PULSED LIGHT SYSTEM
K010927 · Medical Bio Care Sweden AB · Jun 2001
SLT LASERPRO CTH HOLMIUM LASER SYSTEM
K011409 · Surgical Laser Technologies, Inc. · Jun 2001
UNI-LASER 470
K010885 · Medart Corp. · Jun 2001
PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X
K003318 · Paradigm Medical Industries, Inc. · May 2001
K010928 · PROLITE VL PULSED LIGHT SYSTEM
Download PDF FDA Summary Medical Bio Care Swed…