FDA product code · Physical Medicine
ILYLamp, Infrared, Therapeutic Heating
Product code ILY covers Lamp, Infrared, Therapeutic Heating, a Class II device regulated under 21 CFR 890.5500. FDA has cleared 229 devices in this code, 1 of them in the last 12 months. Median review time across the 229 most recent decisions is 151 days. openFDA lists 20 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 890.5500
- Review panel
- Physical Medicine
- Clearances
- 229
What is happening in ILY right now?
ILY (Lamp, Infrared, Therapeutic Heating) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-2162-2026). 1 first-time filer in the last 12 months, Wuhan PHOMED Technology Company , Ltd (K253965). The code is crowded, scoring 70 of 100 — 167 companies hold a clearance here and 1 arrived in the last 12 months (ILY:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2162-2026 |
| New entrant | Worth knowing | K253965 |
| Crowding | Context | ILY:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in ILY?
FDA has cleared 229 devices under product code ILY since the 510(k) programme began in 1976, 1 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253965 | CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) | Wuhan PHOMED Technology Company , Ltd. | |
| K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) | Gigaalaser Company , Ltd. | |
| K231997 | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) | Cure Point Therapeutics, Inc. | |
| K223642 | LED Lip Perfector, model: ZC-05 | Light Tree Ventures Europe B.V. | |
| K221189 | OLIZ LTB-1000A | Ltbio Co., Ltd. | |
| K213524 | CytonPro-5000 | Cytonsys, Inc. | |
| K202028 | dermalux Flex MD | Aesthetic Technology, Ltd. | |
| K171087 | AXON IR Heat Lamp | Crystal Medtech, LLC | |
| K163079 | HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System | Healthlight, LLC | |
| K170068 | Softcure 96 | Wellray Medical Laser, Inc. |
How long does FDA review take for ILY?
The median FDA review time for ILY is 151 days, measured across the 229 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in ILY?
openFDA lists 20 recall records against product code ILY. A recall record covers one firm's corrective action and may span many device lots.
Z-2162-2026Open, ClassifiedTechnological Medical Advancements LLC
Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W.
Z-2416-2025Open, ClassifiedTHOR Photomedicine Ltd
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Z-2417-2025Open, ClassifiedTHOR Photomedicine Ltd
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Z-2418-2025Open, ClassifiedTHOR Photomedicine Ltd
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Z-2419-2025Open, ClassifiedTHOR Photomedicine Ltd
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Showing the 5 most recently initiated of 20. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for ILY?
MAUDE holds 46 adverse-event reports naming product code ILY, 15 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in ILY unusual?
ILY does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history |
20 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered ILY in the last year?
One company filed in ILY for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Wuhan PHOMED Technology Company , Ltd. | K253965 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in ILY?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in ILY?
Across the 229 most recent decisions, these applicants filed most often in ILY.
| Applicant | Recent clearances |
|---|---|
| Usa Laser Biotech, Inc. | 6 |
| Cynosure, Inc. | 4 |
| Dynatronics Corp. | 4 |
| Escada International, Inc. | 4 |
| Meditech International, Inc. | 4 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch ILY
Get an email the morning anything changes in ILY — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.