Cleared Abbreviated

K034009 - LAPEX 2000

K034009 is an FDA 510(k) clearance for LAPEX 2000, manufactured by Meridian Co., Ltd.. The device is a Class 2 Physical Medicine device with product code NHN cleared through the Abbreviated 510(k) pathway after a 394-day FDA review.

K034009 · Meridian Co., Ltd. · Physical Medicine device
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Jan 2005
Decision
394d
Days
Class 2
Risk

K034009 is an FDA 510(k) clearance for the LAPEX 2000. Classified as Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy (product code NHN), Class II - Special Controls.

Submitted by Meridian Co., Ltd. (Deer Field, US). The FDA issued a Cleared decision on January 21, 2005 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Meridian Co., Ltd. devices

FDA 510(k) Submission Details - K034009

510(k) Number K034009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2003
Decision Date January 21, 2005
Days to Decision 394 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
279d slower than avg
Panel avg: 115d · This submission: 394d
Pathway characteristics
Standards-based clearance path.

NHN Device Classification - Class 2, Special Controls

Product Code NHN Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. This Device Emits Energy In The Infrared Or Other Wavelengths, Provides Non-heating And Non-thermal Effect, And Is Indicated For Adjunctive Use In Pain Therapy Or Related Indication. It Does Not Provide Therapeutic Topical Heating. The Classification Regulation For Infrared Lamps Describes A Device That Emits Energy In The Infrared Wavelength To Provide Topical Heating And That Is Not Limited To Adjunctive Use.
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 Physical Medicine devices follow this clearance model.