Cleared Traditional

K010175 - MICROLIGHT 830 LASER SYSTEM

K010175 is an FDA 510(k) clearance for MICROLIGHT 830 LASER SYSTEM, manufactured by Microlight Corporation of America. The device is a Class 2 Physical Medicine device with product code NHN cleared through the Traditional 510(k) pathway after a 384-day FDA review.

K010175 · Microlight Corporation of America · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
384d
Days
Class 2
Risk

K010175 is an FDA 510(k) clearance for the MICROLIGHT 830 LASER SYSTEM. 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 Microlight Corporation of America (Missouri City, US). The FDA issued a Cleared decision on February 6, 2002 after a review of 384 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 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K010175

510(k) Number K010175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2001
Decision Date February 06, 2002
Days to Decision 384 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
268d slower than avg
Panel avg: 116d · This submission: 384d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - NHN Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy

All 53
Devices cleared under the same product code (NHN) and FDA review panel - the closest regulatory comparables to K010175.
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ERCHONIA PL2000
K012580 · Tuco Innovations, Inc. · Jan 2002
K010175 · MICROLIGHT 830 LASER SYSTEM
Download PDF FDA Summary Microlight Corporatio…