Cleared Traditional

K110721 - GAUNYING INFRARED LAMP

K110721 is an FDA 510(k) clearance for GAUNYING INFRARED LAMP, manufactured by Foshan Gaunying Electronics Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K110721 · Foshan Gaunying Electronics Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
15d
Days
Class 2
Risk

K110721 is an FDA 510(k) clearance for the GAUNYING INFRARED LAMP. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Foshan Gaunying Electronics Co., Ltd. (Foshan, Guangdong, CN). The FDA issued a Cleared decision on March 30, 2011 after a review of 15 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Foshan Gaunying Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K110721

510(k) Number K110721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2011
Decision Date March 30, 2011
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 31
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K110721.
HEALITE II SYSTEM
K113668 · Lutronic Corporation · Jun 2012
DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE
K113250 · Dynatronics Corp. · Feb 2012
ASA 'MPHI FAMILY DIODE LASER
K111901 · Cynosure, Inc. · Nov 2011
THERMAPULSE
K092222 · Palomar Medical Products, Inc. · Aug 2009
EZLASE
K083595 · Biolase Technology, Inc. · Apr 2009
DYNATRON DX2 TRACTION UNIT
K051680 · Dynatronics Corp. · Oct 2005