Cleared Traditional

K042813 - BIOBEAM NARROW BAND LIGHT THERAPY DEVICES

K042813 is an FDA 510(k) clearance for BIOBEAM NARROW BAND LIGHT THERAPY DEVICES, manufactured by Life Without Pain, LLC. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K042813 · Life Without Pain, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
136d
Days
Class 2
Risk

K042813 is an FDA 510(k) clearance for the BIOBEAM NARROW BAND LIGHT THERAPY DEVICES. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Life Without Pain, LLC (North Attleboro, US). The FDA issued a Cleared decision on February 25, 2005 after a review of 136 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 - K042813

510(k) Number K042813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2004
Decision Date February 25, 2005
Days to Decision 136 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
20d slower than avg
Panel avg: 116d · This submission: 136d
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 K042813.
MEDX HOME
K050022 · Medx Electronics, Inc. · May 2005
K-LASER, MODELS 3,4,4D,6D
K050070 · Eltech S.R.L · Mar 2005
OMNILUX PLUS
K043317 · Photo Therapeutics Limited · Mar 2005
BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS
K041885 · Meditech International, Inc. · Feb 2005
COLD LIGHT
K041679 · Onyx Medical, Inc. · Dec 2004
ML830 LASER SYSTEM
K041364 · Microlight Corporation of America · Dec 2004
K042813 · BIOBEAM NARROW BAND LIGHT THERAPY DEVICES
Download PDF FDA Summary Life Without Pain, LLC