ILY · Class II · 21 CFR 890.5500

FDA Product Code ILY: Lamp, Infrared, Therapeutic Heating

Leading manufacturers include Cynosure, Inc., Olympic Medical Corp. and Fisher &Paykel Healthcare , Ltd..

229
Total
229
Cleared
168d
Avg days
1985
Since
Growing category - 3 submissions in the last 2 years vs 2 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
1–24 of 229
Cleared Mar 19, 2026
CureLight Medical Diode Laser Systems (CureLight F2-A15
K253965
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)
K242755
Gigaalaser Company , Ltd.
General & Plastic Surgery · 249d
Cleared Oct 15, 2024
SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
K231997
Cure Point Therapeutics, Inc.
General & Plastic Surgery · 468d
Cleared Mar 09, 2023
LED Lip Perfector, model: ZC-05
K223642
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 93d
Cleared Aug 29, 2022
OLIZ LTB-1000A
K221189
Ltbio Co., Ltd.
Physical Medicine · 126d
Cleared Aug 10, 2022
CytonPro-5000
K213524
Cytonsys, Inc.
Physical Medicine · 280d
Cleared Dec 16, 2020
dermalux Flex MD
K202028
Aesthetic Technology, Ltd.
General & Plastic Surgery · 147d
Cleared May 02, 2013
CYNOSURE 1064NM DIODE LASER
K123971
Cynosure, Inc.
Physical Medicine · 127d
Cleared Nov 09, 2011
ASA 'MPHI FAMILY DIODE LASER
K111901
Cynosure, Inc.
Physical Medicine · 127d
Cleared Sep 26, 2005
HILT FAMILY LASER: HILT I, HILT II, HILT III
K051537
Cynosure, Inc.
Physical Medicine · 108d
Cleared Sep 14, 2005
ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6
K051922
Cynosure, Inc.
Physical Medicine · 61d
Cleared May 07, 2004
RICH-MAR AUTOPRISM INFRARED LAMP
K040679
Rich-Mar Corp.
Physical Medicine · 53d
Cleared Mar 06, 2003
SURGICAL PATIENT WARMER, MODEL PW820 JHU
K022609
Fisher &Paykel Healthcare , Ltd.
Physical Medicine · 212d
Cleared Sep 29, 2000
OLYMPIC WARM-UP
K001056
Olympic Medical Corp.
Physical Medicine · 179d
Cleared Oct 26, 1998
PATIENT WARMER- MODEL PW810
K982636
Fisher &Paykel Healthcare , Ltd.
Physical Medicine · 89d
Cleared Jan 26, 1994
OLYMPIC WARM-LAMP
K932881
Olympic Medical Corp.
Physical Medicine · 226d

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 2 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 →