Cleared Traditional

K082686 - MULTI-CHANNEL LASER THERAPY SYSTEM

K082686 is an FDA 510(k) clearance for MULTI-CHANNEL LASER THERAPY SYSTEM, manufactured by United Integrated Services Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K082686 · United Integrated Services Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
238d
Days
Class 2
Risk

K082686 is an FDA 510(k) clearance for the MULTI-CHANNEL LASER THERAPY SYSTEM. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by United Integrated Services Co., Ltd. (Hsintien City, Taipei Hsien, TW). The FDA issued a Cleared decision on May 11, 2009 after a review of 238 days - an extended review 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: 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 - K082686

510(k) Number K082686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2008
Decision Date May 11, 2009
Days to Decision 238 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
122d slower than avg
Panel avg: 116d · This submission: 238d
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 216
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K082686.
AKLARUS PHOTOTHERAPY SYSTEM
K083183 · Hill Laboratories Co. · Jul 2009
ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301
K083580 · Led Intellectual Properties, LLC · Jun 2009
PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS
K081720 · Prime Herbs Corporation · Jun 2009
NEUTROLUMENPN SYSTEM, MODEL 1000
K082223 · Neurolumen, LLC · Apr 2009
EZLASE
K083595 · Biolase Technology, Inc. · Apr 2009
LAPEX BCS
K081962 · Meridian Co., Ltd. · Dec 2008
K082686 · MULTI-CHANNEL LASER THERAPY SYSTEM
Download PDF FDA Summary United Integrated Ser…