Cleared Traditional

K033986 - MLT-1000 IR LASER SYSTEM

K033986 is an FDA 510(k) clearance for MLT-1000 IR LASER SYSTEM, manufactured by Medical Laser Therapeutics LP. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K033986 · Medical Laser Therapeutics LP · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
97d
Days
Class 2
Risk

K033986 is an FDA 510(k) clearance for the MLT-1000 IR LASER SYSTEM. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Medical Laser Therapeutics LP (Houston, US). The FDA issued a Cleared decision on March 29, 2004 after a review of 97 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 - K033986

510(k) Number K033986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2003
Decision Date March 29, 2004
Days to Decision 97 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
19d faster than avg
Panel avg: 116d · This submission: 97d
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 K033986.
SOLARIS D890 THERAPY PROBE
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RICH-MAR AUTOPRISM INFRARED LAMP
K040679 · Rich-Mar Corp. · May 2004
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
K033986 · MLT-1000 IR LASER SYSTEM
Download PDF FDA Summary Medical Laser Therape…