Cleared Traditional

K041419 - LIGHTFORCE LF 20/30 980NM SURGICAL DIOD...

K041419 is the FDA 510(k) clearance for LIGHTFORCE LF 20/30 980NM SURGICAL DIOD... by Medical Energy, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K041419 · Medical Energy, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
90d
Days
Class 2
Risk

K041419 is an FDA 510(k) clearance for the LIGHTFORCE LF 20/30 980NM SURGICAL DIODE 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 Medical Energy, Inc. (Pensacola, US). The FDA issued a Cleared decision on August 26, 2004 after a review of 90 days - within the typical 510(k) review window.

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 Medical Energy, Inc. devices

Submission Details

510(k) Number K041419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2004
Decision Date August 26, 2004
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
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 737
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K041419.
CYNERGY LASER
K043429 · Cynosure, Inc. · Jan 2005
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
K042785 · Nidek, Inc. · Dec 2004
EDWARDS E360 SURGICAL ABLATION DEVICE
K041739 · Edwards Lifesciences, LLC · Sep 2004
PHOTOSILK PULSED LIGHT SYSTEM
K041095 · Cynosure, Inc. · May 2004
SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER
K040289 · Cynosure, Inc. · Apr 2004
APOGEE ELITE
K034030 · Cynosure, Inc. · Feb 2004