Cleared Traditional

K081166 - LIGHTSTREAM LOW LEVEL LASER

K081166 is an FDA 510(k) clearance for LIGHTSTREAM LOW LEVEL LASER, manufactured by Solica Corporation. The device is a Class 2 Physical Medicine device with product code NHN cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K081166 · Solica Corporation · Physical Medicine device
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Apr 2009
Decision
344d
Days
Class 2
Risk

K081166 is an FDA 510(k) clearance for the LIGHTSTREAM LOW LEVEL LASER. 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 Solica Corporation (Toronto, Ontario, CA). The FDA issued a Cleared decision on April 3, 2009 after a review of 344 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.

View all Solica Corporation devices

FDA 510(k) Submission Details - K081166

510(k) Number K081166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2008
Decision Date April 03, 2009
Days to Decision 344 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
229d slower than avg
Panel avg: 115d · This submission: 344d
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.