Cleared Traditional

K050070 - K-LASER, MODELS 3,4,4D,6D

K050070 is an FDA 510(k) clearance for K-LASER, manufactured by Eltech S.R.L. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K050070 · Eltech S.R.L · Physical Medicine device
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Mar 2005
Decision
72d
Days
Class 2
Risk

K050070 is an FDA 510(k) clearance for the K-LASER, MODELS 3,4,4D,6D. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Eltech S.R.L (Franklin, US). The FDA issued a Cleared decision on March 25, 2005 after a review of 72 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Eltech S.R.L devices

FDA 510(k) Submission Details - K050070

510(k) Number K050070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2005
Decision Date March 25, 2005
Days to Decision 72 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
43d faster than avg
Panel avg: 115d · This submission: 72d
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 38
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K050070.
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