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) Official FDA 510(k) Summary (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.

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
11d slower than avg
Panel avg: 116d · 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 227
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K111901.
WARP10,WARP75
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YOLO CURVE
K110342 · Yolo Medical, Inc. · Aug 2011
GAUNYING INFRARED LAMP
K110721 · Foshan Gaunying Electronics Co., Ltd. · Mar 2011
LUCIA
K102375 · Meridian Co., Ltd. · Feb 2011
K111901 · ASA 'MPHI FAMILY DIODE LASER
Download PDF FDA Summary Cynosure, Inc.