ClearanceBrief
Panels › Physical Medicine › Product code ILY · Class 2

Lamp, Infrared, Therapeutic Heating

Regulation 890.5500

1510(k)s in 12 months (229 all time)
2recalls in 12 months (20 all time)
9recalls that name a 510(k)
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Top companies in ILY

Company510(k)sRecalls
THOR Photomedicine Ltd09
Usa Laser Biotech, Inc.60
Cynosure, Inc.40
Dynatronics Corp.40
Escada International, Inc.40
Meditech International, Inc.40
Medx Electronics, Inc.40
Biocare Systems, Inc.21
Biophotas, Inc.30
Bioscan, Inc.30
DateFirm and productCodeLinked 510(k)
Jun 17, 2026MITO RED LIGHT INC
Mito Red Light, Super Mobile
Open, Classified
ILYNone listed
May 11, 2026Technological Medical Advancements LLC
Diowave Laser System, REF: Diowave 250W
Open, Classified
ILYK121363
Aug 22, 2025THOR Photomedicine Ltd
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible a
Open, Classified
ILYNone listed
Aug 22, 2025THOR Photomedicine Ltd
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible a
Open, Classified
ILYNone listed
Aug 22, 2025THOR Photomedicine Ltd
Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectru
Open, Classified
ILYNone listed
Aug 22, 2025THOR Photomedicine Ltd
Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum t
Open, Classified
ILYNone listed
Feb 1, 2024THOR Photomedicine Ltd
NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL
Open, Classified
ILYNone listed
Dec 1, 2023Thor Photomedicine Ltd
NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.
Open, Classified
ILYNone listed
Dec 1, 2023Thor Photomedicine Ltd
NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
Open, Classified
ILYNone listed
Dec 1, 2023Thor Photomedicine Ltd
G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177
Open, Classified
ILYNone listed
Dec 1, 2023Thor Photomedicine Ltd
NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
Open, Classified
ILYNone listed
Jun 4, 2019Inlightened Partners LLC
inLight Medical LED Pads used with Polychromatic light technology system
Terminated
ILYK153389
Apr 28, 2016LED Technologies, LLC
reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm direc
Terminated
ILYK081570
Mar 6, 2015Pivotal Health Solutions
Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tis
Terminated
ILYK060134
Dec 12, 2012Quasar Bio-Tech, Inc. dba Silver Bay LLC
Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to be used in combination with the Baby Quasar to treat acne. The Q
Terminated
ILYK051046
Dec 12, 2012Quasar Bio-Tech, Inc. dba Silver Bay LLC
Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 O
Terminated
ILYK051046
Dec 12, 2012Quasar Bio-Tech, Inc. dba Silver Bay LLC
Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Se
Terminated
ILYK051046
Nov 9, 2010Cutera Inc
Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc, Brisbane, CA Infrared therapeutic heating lamp, intended to emit energy in the infrared spectrum to provide topical he
Terminated
ILYK042165
Aug 7, 2009Suarez Corporation Industries
Foot Choice Therapeutic Foot Massager, Model Number YS-322. The device is a heated foot massager intended for over the counter use.
Terminated
ILYNone listed
Aug 24, 2006Biocare Systems Inc.
LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc.
Terminated
ILYK051816

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