Cleared Traditional

ALT LASER, MODEL VTR 75 (K031612) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K031612 · Avicenna Laser Technology, Inc. · Physical Medicine device
Download Printable Device Report (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.

View all Avicenna Laser Technology, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 115d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K031612.
CureLight Medical Diode Laser Systems (CureLight F2-A15
K253965 · Wuhan PHOMED Technology Company , Ltd. · Mar 2026
Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
K242755 · Gigaalaser Company , Ltd. · May 2025
SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
K231997 · Cure Point Therapeutics, Inc. · Oct 2024
LED Lip Perfector, model: ZC-05
K223642 · Light Tree Ventures Europe B.V. · Mar 2023
OLIZ LTB-1000A
K221189 · Ltbio Co., Ltd. · Aug 2022
CytonPro-5000
K213524 · Cytonsys, Inc. · Aug 2022