Cleared Traditional

K041829 - FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS

K041829 is an FDA 510(k) clearance for FOCUS MEDICAL NATURALASE LP AND NATURAL..., manufactured by Focus Medical, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K041829 · Focus Medical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
62d
Days
Class 2
Risk

K041829 is an FDA 510(k) clearance for the FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS. 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 Focus Medical, LLC (Bethel, US). The FDA issued a Cleared decision on September 7, 2004 after a review of 62 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 - K041829

510(k) Number K041829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2004
Decision Date September 07, 2004
Days to Decision 62 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
53d faster than avg
Panel avg: 115d · This submission: 62d
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 2671
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K041829.
VARILITE LASER SYSTEM
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K041660 · Trimedyne, Inc. · Sep 2004
LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM
K041419 · Medical Energy, Inc. · Aug 2004
DURALITE-GL
K041262 · Laser Scientific · Aug 2004
LVI AESTHETIC LASER
K041721 · Hoya Photonics, Inc. · Aug 2004