Cleared Traditional

K101893 - NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS

K101893 is an FDA 510(k) clearance for NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, manufactured by Usa Laser Biotech, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K101893 · Usa Laser Biotech, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
225d
Days
Class 2
Risk

K101893 is an FDA 510(k) clearance for the NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, .... Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Usa Laser Biotech, Inc. (Houston, US). The FDA issued a Cleared decision on February 17, 2011 after a review of 225 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 - K101893

510(k) Number K101893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2010
Decision Date February 17, 2011
Days to Decision 225 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
109d slower than avg
Panel avg: 116d · This submission: 225d
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 215
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K101893.
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
LITECURE THERAPY SYSTEM
K103511 · Litecure, LLC · Jan 2011
HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT
K101894 · Bioremedi Therapeutic Systems, Inc. · Jan 2011
HVR PAIN RELIEF DEVICE
K101716 · H.V.R., Inc. · Jan 2011