Cleared Traditional

K160947 - LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System

K160947 is an FDA 510(k) clearance for LUMIX CPS 1 IR Lamp System LUMIX CPS 2 ..., 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 91-day FDA review.

K160947 · 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
Jul 2016
Decision
91d
Days
Class 2
Risk

K160947 is an FDA 510(k) clearance for the LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp Sys.... Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Usa Laser Biotech, Inc. (Richmond, US). The FDA issued a Cleared decision on July 5, 2016 after a review of 91 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 - K160947

510(k) Number K160947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2016
Decision Date July 05, 2016
Days to Decision 91 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
25d faster than avg
Panel avg: 116d · This submission: 91d
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 Consultant

Texas Applied Biomedical Services, Inc.
M. JOYCE HEINRICH

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K160947.
Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3
K161198 · Usa Laser Biotech, Inc. · Jul 2016
The Time Machine Series Lasers
K152461 · Medical Lasers Manufacturer, Inc. · Jul 2016
LightStim Professional LED Bed
K153399 · Led Intellectual Properties, LLC · Jul 2016
Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)
K153389 · In Light Wellness Systems, Inc. · Mar 2016
BioPhotas Celluma3
K152280 · Biophotas, Inc. · Mar 2016
Varaya Sport
K150716 · Varaya Photoceuticals, LLC · Dec 2015