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)
Top companies in ILY
| Company | 510(k)s | Recalls |
|---|---|---|
| THOR Photomedicine Ltd | 0 | 9 |
| Usa Laser Biotech, Inc. | 6 | 0 |
| Cynosure, Inc. | 4 | 0 |
| Dynatronics Corp. | 4 | 0 |
| Escada International, Inc. | 4 | 0 |
| Meditech International, Inc. | 4 | 0 |
| Medx Electronics, Inc. | 4 | 0 |
| Biocare Systems, Inc. | 2 | 1 |
| Biophotas, Inc. | 3 | 0 |
| Bioscan, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 17, 2026 | MITO RED LIGHT INC Mito Red Light, Super Mobile Open, Classified |
ILY | None listed |
| May 11, 2026 | Technological Medical Advancements LLC Diowave Laser System, REF: Diowave 250W Open, Classified |
ILY | K121363 |
| Aug 22, 2025 | THOR 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 |
ILY | None listed |
| Aug 22, 2025 | THOR 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 |
ILY | None listed |
| Aug 22, 2025 | THOR 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 |
ILY | None listed |
| Aug 22, 2025 | THOR 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 |
ILY | None listed |
| Feb 1, 2024 | THOR 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 |
ILY | None listed |
| Dec 1, 2023 | Thor Photomedicine Ltd NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184. Open, Classified |
ILY | None listed |
| Dec 1, 2023 | Thor Photomedicine Ltd NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183 Open, Classified |
ILY | None listed |
| Dec 1, 2023 | Thor Photomedicine Ltd G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177 Open, Classified |
ILY | None listed |
| Dec 1, 2023 | Thor Photomedicine Ltd NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176 Open, Classified |
ILY | None listed |
| Jun 4, 2019 | Inlightened Partners LLC inLight Medical LED Pads used with Polychromatic light technology system Terminated |
ILY | K153389 |
| Apr 28, 2016 | LED 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 |
ILY | K081570 |
| Mar 6, 2015 | Pivotal 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 |
ILY | K060134 |
| Dec 12, 2012 | Quasar 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 |
ILY | K051046 |
| Dec 12, 2012 | Quasar 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 |
ILY | K051046 |
| Dec 12, 2012 | Quasar 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 |
ILY | K051046 |
| Nov 9, 2010 | Cutera 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 |
ILY | K042165 |
| Aug 7, 2009 | Suarez 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 |
ILY | None listed |
| Aug 24, 2006 | Biocare Systems Inc. LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc. Terminated |
ILY | K051816 |
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