Cleared Traditional

K091497 - K-LASER K-1200, MODEL 12 W

K091497 is an FDA 510(k) clearance for K-LASER K-1200, 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 91-day FDA review.

K091497 · Eltech S.R.L · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
91d
Days
Class 2
Risk

K091497 is an FDA 510(k) clearance for the K-LASER K-1200, MODEL 12 W. 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 August 19, 2009 after a review of 91 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K091497

510(k) Number K091497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2009
Decision Date August 19, 2009
Days to Decision 91 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
25d faster than avg
Panel avg: 116d · This submission: 91d
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 222
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K091497.
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K091497 · K-LASER K-1200, MODEL 12 W
Download PDF FDA Summary Eltech S.R.L