Cleared Traditional

K051537 - HILT FAMILY LASER: HILT I, HILT II, HILT III

K051537 is an FDA 510(k) clearance for HILT FAMILY LASER: HILT I, manufactured by Cynosure, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K051537 · Cynosure, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
108d
Days
Class 2
Risk

K051537 is an FDA 510(k) clearance for the HILT FAMILY LASER: HILT I, HILT II, HILT III. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Cynosure, Inc. (Chelmsford, US). The FDA issued a Cleared decision on September 26, 2005 after a review of 108 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 - K051537

510(k) Number K051537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2005
Decision Date September 26, 2005
Days to Decision 108 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
8d faster than avg
Panel avg: 116d · This submission: 108d
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 227
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K051537.
IRRADIA MID - LASER (S3)
K051548 · Irradia AB · Oct 2005
DYNATRON DX2 TRACTION UNIT
K051680 · Dynatronics Corp. · Oct 2005
HUANQIU HEATING LAMP
K052063 · A & A Medical Supplies, Inc. · Sep 2005
ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6
K051922 · Cynosure, Inc. · Sep 2005
LUMIWAVE 1X4 INFRARED THERAPY DEVICE
K051816 · Biocare Systems, Inc. · Aug 2005
DERMILLUME RED, MODEL HR1000
K051681 · Care Electronics, Inc. · Jul 2005
K051537 · HILT FAMILY LASER: HILT I, HILT II, HILT III
Download PDF FDA Summary Cynosure, Inc.