Cleared Special

K111901 - ASA 'MPHI FAMILY DIODE LASER

K111901 is an FDA 510(k) clearance for ASA 'MPHI FAMILY DIODE LASER, manufactured by Cynosure, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Special 510(k) pathway after a 127-day FDA review.

K111901 · Cynosure, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
127d
Days
Class 2
Risk

K111901 is an FDA 510(k) clearance for the ASA 'MPHI FAMILY DIODE LASER. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Cynosure, Inc. (Wesford, US). The FDA issued a Cleared decision on November 9, 2011 after a review of 127 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cynosure, Inc. devices

FDA 510(k) Submission Details - K111901

510(k) Number K111901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2011
Decision Date November 09, 2011
Days to Decision 127 days
Submission Type Special
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
12d slower than avg
Panel avg: 115d · This submission: 127d
Pathway characteristics
Modification to existing cleared device.

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 61
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