Cleared Traditional

K012508 - MU PHOTONICS PAIN THERAPIST

K012508 is an FDA 510(k) clearance for MU PHOTONICS PAIN THERAPIST, manufactured by Nu Photonics, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K012508 · Nu Photonics, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
64d
Days
Class 2
Risk

K012508 is an FDA 510(k) clearance for the MU PHOTONICS PAIN THERAPIST. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Nu Photonics, Inc. (Denver, US). The FDA issued a Cleared decision on October 9, 2001 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K012508

510(k) Number K012508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2001
Decision Date October 09, 2001
Days to Decision 64 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 116d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Entela, Inc.
NED E DEVINE

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 228
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K012508.
MEDX 1000 SERIES
K020017 · Medx Electronics, Inc. · Jul 2002
SSIR SYSTEM
K014208 · Russian-American Technology Associates, Inc. · Jul 2002
BIOLIGHT PCD
K011355 · Biolight International AB · Jan 2002
TDP CQ-27 HEAT LAMP
K003538 · Lhasa Medical, Inc. · Jun 2001
SUPER NOVA, ACUBEAM
K001179 · Light Force Therapy, Inc. · Oct 2000
OLYMPIC WARM-UP
K001056 · Olympic Medical Corp. · Sep 2000

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K012508 · MU PHOTONICS PAIN THERAPIST
Download PDF FDA Summary Nu Photonics, Inc.