FDA Product Code ILY: Lamp, Infrared, Therapeutic Heating
Leading manufacturers include Dynatronics Corp., Cynosure, Inc. and Usa Laser Biotech, Inc..
229
Total
229
Cleared
168d
Avg days
1985
Since
Growing category -
3 submissions in the last 2 years
vs 1 in the prior period
Review times increasing: avg
272d
recently vs 167d historically
FDA 510(k) Cleared Lamp, Infrared, Therapeutic Heating Devices (Product Code ILY)
229 devices
Cleared
Mar 19, 2026
CureLight Medical Diode Laser Systems (CureLight F2-A15
Wuhan PHOMED Technology Company , Ltd.
General & Plastic Surgery
98d
Cleared
May 19, 2025
Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
Gigaalaser Company , Ltd.
General & Plastic Surgery
249d
Cleared
Oct 15, 2024
SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
Cure Point Therapeutics, Inc.
General & Plastic Surgery
468d
Cleared
Mar 09, 2023
LED Lip Perfector, model: ZC-05
Light Tree Ventures Europe B.V.
General & Plastic Surgery
93d
Cleared
Aug 29, 2022
OLIZ LTB-1000A
Ltbio Co., Ltd.
Physical Medicine
126d
Cleared
Aug 10, 2022
CytonPro-5000
Cytonsys, Inc.
Physical Medicine
280d
Cleared
Dec 16, 2020
dermalux Flex MD
Aesthetic Technology, Ltd.
General & Plastic Surgery
147d
Cleared
Jul 07, 2017
AXON IR Heat Lamp
Crystal Medtech, LLC
Physical Medicine
86d
Cleared
Jun 13, 2017
HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System
Healthlight, LLC
Physical Medicine
222d
Cleared
May 05, 2017
Softcure 96
Wellray Medical Laser, Inc.
Physical Medicine
116d
Cleared
Feb 14, 2017
Bashan TDP Heat Lamp
Chogqing Yuhe Medical Instruments Co., Ltd.
Physical Medicine
151d
Cleared
Jan 05, 2017
Vevazz LED Heat Lamp
Vevazz, LLC
Physical Medicine
97d
Cleared
Dec 15, 2016
WS(TM) Far-Infrared Therapy Unit, Model KP-B210
Ws Far IR Medical Technology Co., Ltd.
Physical Medicine
262d
Cleared
Jul 29, 2016
HeatLux Pro II
Home Skinovations , Ltd.
Physical Medicine
368d
Cleared
Jul 26, 2016
Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3
Usa Laser Biotech, Inc.
Physical Medicine
89d
Cleared
Jul 08, 2016
The Time Machine Series Lasers
Medical Lasers Manufacturer, Inc.
Physical Medicine
315d
Cleared
Jul 05, 2016
LightStim Professional LED Bed
Led Intellectual Properties, LLC
Physical Medicine
224d
Cleared
Jul 05, 2016
LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System
Usa Laser Biotech, Inc.
Physical Medicine
91d
Cleared
Mar 30, 2016
Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)
In Light Wellness Systems, Inc.
Physical Medicine
128d
Cleared
Mar 02, 2016
BioPhotas Celluma3
Biophotas, Inc.
Physical Medicine
203d
Cleared
Dec 08, 2015
Varaya Sport
Varaya Photoceuticals, LLC
Physical Medicine
264d
Cleared
Oct 06, 2015
NuBrilliance Light Pain Therapy
Wellquest International, Inc.
Physical Medicine
216d
Cleared
Sep 04, 2015
Phoenix Thera-Lase System
Phoenix Thera-Lase Systems, LLC
Physical Medicine
91d
Cleared
Aug 21, 2015
LightStim for Pain LED Belt
Led Intellectual Properties, LLC
Physical Medicine
94d
About Product Code ILY - Regulatory Context
510(k) Submission Activity
229 total 510(k) submissions under product code ILY since 1985, with 229 receiving FDA clearance (average review time: 168 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - ILY Product Code
Recent submissions under ILY have taken an average of 272 days to reach a decision - up from 167 days historically. Manufacturers should account for longer review timelines in current project planning.
ILY devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →