Cleared Traditional

K152461 - The Time Machine Series Lasers (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152461 · Medical Lasers Manufacturer, Inc. · Physical Medicine device
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Jul 2016
Decision
315d
Days
Class 2
Risk

K152461 is an FDA 510(k) clearance for the The Time Machine Series Lasers. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Medical Lasers Manufacturer, Inc. (Freehold, US). The FDA issued a Cleared decision on July 8, 2016 after a review of 315 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 Medical Lasers Manufacturer, Inc. devices

Submission Details

510(k) Number K152461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2015
Decision Date July 08, 2016
Days to Decision 315 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
200d slower than avg
Panel avg: 115d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 - ILY Lamp, Infrared, Therapeutic Heating

All 228
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