Cleared Traditional

K152461 - The Time Machine Series Lasers

K152461 is an FDA 510(k) clearance for The Time Machine Series Lasers, manufactured by Medical Lasers Manufacturer, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K152461 · Medical Lasers Manufacturer, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K152461

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.

ILY Device Classification - Class 2, Special Controls

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 31
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