Cleared Traditional

K011355 - BIOLIGHT PCD

K011355 is an FDA 510(k) clearance for BIOLIGHT PCD, manufactured by Biolight International AB. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K011355 · Biolight International AB · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
259d
Days
Class 2
Risk

K011355 is an FDA 510(k) clearance for the BIOLIGHT PCD. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Biolight International AB (Minneapolis,, US). The FDA issued a Cleared decision on January 17, 2002 after a review of 259 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 - K011355

510(k) Number K011355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2001
Decision Date January 17, 2002
Days to Decision 259 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
143d slower than avg
Panel avg: 116d · This submission: 259d
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 228
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K011355.
MHS MED LIGHT 1000
K021956 · Micro Health Systems, Inc. · Aug 2002
MEDX 1000 SERIES
K020017 · Medx Electronics, Inc. · Jul 2002
SSIR SYSTEM
K014208 · Russian-American Technology Associates, Inc. · Jul 2002
MU PHOTONICS PAIN THERAPIST
K012508 · Nu Photonics, Inc. · Oct 2001
TDP CQ-27 HEAT LAMP
K003538 · Lhasa Medical, Inc. · Jun 2001
SUPER NOVA, ACUBEAM
K001179 · Light Force Therapy, Inc. · Oct 2000
K011355 · BIOLIGHT PCD
Download PDF FDA Summary Biolight Internationa…