Cleared Traditional

K032379 - QUASAR, MODEL MD21

K032379 is an FDA 510(k) clearance for QUASAR, manufactured by Quantum Skincare, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K032379 · Quantum Skincare, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
111d
Days
Class 2
Risk

K032379 is an FDA 510(k) clearance for the QUASAR, MODEL MD21. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Quantum Skincare, Inc. (Houston, US). The FDA issued a Cleared decision on November 20, 2003 after a review of 111 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 - K032379

510(k) Number K032379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2003
Decision Date November 20, 2003
Days to Decision 111 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
5d faster than avg
Panel avg: 116d · This submission: 111d
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 K032379.
ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE
K033768 · Altus Medical, Inc. · Feb 2004
ALT LASER, MODEL VTR 75
K031612 · Avicenna Laser Technology, Inc. · Dec 2003
LIGHTWAVE INFRARED LAMPS LW10D AND LW30D
K024027 · Skytech Enterprises, Inc. · Dec 2003
NEUROLASE, MODELS 150V, 150C, 1064
K032787 · Spectrum Laser & Technologies · Nov 2003
TLC MODELS ULK-H AND ULT-H INFRARED LAMPS
K033035 · Tlc Marketing, Inc. · Nov 2003
EM PROBE, EM PAD
K024361 · Em Probe, Inc. · Oct 2003
K032379 · QUASAR, MODEL MD21
Download PDF FDA Summary Quantum Skincare, Inc.