Cleared Traditional

K031612 - ALT LASER, MODEL VTR 75

K031612 is an FDA 510(k) clearance for ALT LASER, manufactured by Avicenna Laser Technology, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K031612 · Avicenna Laser Technology, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
203d
Days
Class 2
Risk

K031612 is an FDA 510(k) clearance for the ALT LASER, MODEL VTR 75. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Avicenna Laser Technology, Inc. (West Palm Beach, US). The FDA issued a Cleared decision on December 11, 2003 after a review of 203 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 - K031612

510(k) Number K031612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2003
Decision Date December 11, 2003
Days to Decision 203 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
87d slower than avg
Panel avg: 116d · This submission: 203d
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 222
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K031612.
TH0R DDII IR LAMP SYSTEM
K033923 · Thor Intl. · Mar 2004
KENKOWAVE INFRARED PAIN TREATMENT SYSTEM
K033555 · Kaylight Corporation · Mar 2004
ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE
K033768 · Altus Medical, Inc. · Feb 2004
LIGHTWAVE INFRARED LAMPS LW10D AND LW30D
K024027 · Skytech Enterprises, Inc. · Dec 2003
QUASAR, MODEL MD21
K032379 · Quantum Skincare, Inc. · Nov 2003
NEUROLASE, MODELS 150V, 150C, 1064
K032787 · Spectrum Laser & Technologies · Nov 2003
K031612 · ALT LASER, MODEL VTR 75
Download PDF FDA Summary Avicenna Laser Techno…