{
  "code": "ILY",
  "deviceName": "Lamp, Infrared, Therapeutic Heating",
  "deviceClass": "II",
  "regulationNumber": "890.5500",
  "panel": "Physical Medicine",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 229,
    "last12Months": 1
  },
  "adverseEvents": {
    "total": 46,
    "last12Months": 15
  },
  "reviewDays": {
    "median": 151,
    "sampleSize": 229
  },
  "recalls": {
    "total": 20,
    "recent": [
      {
        "resNumber": "Z-2162-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Technological Medical Advancements LLC",
        "firmAsPublished": "Technological Medical Advancements LLC",
        "reason": "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.",
        "initiated": "2026-01-09"
      },
      {
        "resNumber": "Z-2416-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "THOR Photomedicine Ltd",
        "firmAsPublished": "THOR Photomedicine Ltd",
        "reason": "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.",
        "initiated": "2025-07-24"
      },
      {
        "resNumber": "Z-2417-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "THOR Photomedicine Ltd",
        "firmAsPublished": "THOR Photomedicine Ltd",
        "reason": "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.",
        "initiated": "2025-07-24"
      },
      {
        "resNumber": "Z-2418-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "THOR Photomedicine Ltd",
        "firmAsPublished": "THOR Photomedicine Ltd",
        "reason": "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.",
        "initiated": "2025-07-24"
      },
      {
        "resNumber": "Z-2419-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "THOR Photomedicine Ltd",
        "firmAsPublished": "THOR Photomedicine Ltd",
        "reason": "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.",
        "initiated": "2025-07-24"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253965",
      "deviceName": "CureLight Medical Diode Laser Systems (CureLight F2-A15;  CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)",
      "applicant": "Wuhan PHOMED Technology Company , Ltd.",
      "company": "Wuhan PHOMED Technology Company , Ltd.",
      "decisionDate": "2026-03-19",
      "dateReceived": "2025-12-11"
    },
    {
      "kNumber": "K242755",
      "deviceName": "Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)",
      "applicant": "Gigaalaser Company , Ltd.",
      "company": "Gigaalaser Company , Ltd.",
      "decisionDate": "2025-05-19",
      "dateReceived": "2024-09-12"
    },
    {
      "kNumber": "K231997",
      "deviceName": "SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)",
      "applicant": "Cure Point Therapeutics, Inc.",
      "company": "Cure Point Therapeutics, Inc.",
      "decisionDate": "2024-10-15",
      "dateReceived": "2023-07-05"
    },
    {
      "kNumber": "K223642",
      "deviceName": "LED Lip Perfector, model: ZC-05",
      "applicant": "Light Tree Ventures Europe B.V.",
      "company": "Light Tree Ventures Europe B.V.",
      "decisionDate": "2023-03-09",
      "dateReceived": "2022-12-06"
    },
    {
      "kNumber": "K221189",
      "deviceName": "OLIZ LTB-1000A",
      "applicant": "Ltbio Co., Ltd.",
      "company": "Ltbio Co., Ltd.",
      "decisionDate": "2022-08-29",
      "dateReceived": "2022-04-25"
    },
    {
      "kNumber": "K213524",
      "deviceName": "CytonPro-5000",
      "applicant": "Cytonsys, Inc.",
      "company": "Cytonsys, Inc.",
      "decisionDate": "2022-08-10",
      "dateReceived": "2021-11-03"
    },
    {
      "kNumber": "K202028",
      "deviceName": "dermalux Flex MD",
      "applicant": "Aesthetic Technology, Ltd.",
      "company": "Aesthetic Technology, Ltd.",
      "decisionDate": "2020-12-16",
      "dateReceived": "2020-07-22"
    },
    {
      "kNumber": "K171087",
      "deviceName": "AXON IR Heat Lamp",
      "applicant": "Crystal Medtech, LLC",
      "company": "Crystal Medtech, LLC",
      "decisionDate": "2017-07-07",
      "dateReceived": "2017-04-12"
    },
    {
      "kNumber": "K163079",
      "deviceName": "HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System",
      "applicant": "Healthlight, LLC",
      "company": "Healthlight, LLC",
      "decisionDate": "2017-06-13",
      "dateReceived": "2016-11-03"
    },
    {
      "kNumber": "K170068",
      "deviceName": "Softcure 96",
      "applicant": "Wellray Medical Laser, Inc.",
      "company": "Wellray Medical Laser, Inc.",
      "decisionDate": "2017-05-05",
      "dateReceived": "2017-01-09"
    }
  ],
  "topApplicants": [
    {
      "name": "Usa Laser Biotech, Inc.",
      "count": 6
    },
    {
      "name": "Cynosure, Inc.",
      "count": 4
    },
    {
      "name": "Dynatronics Corp.",
      "count": 4
    },
    {
      "name": "Escada International, Inc.",
      "count": 4
    },
    {
      "name": "Meditech International, Inc.",
      "count": 4
    }
  ],
  "topCompanies": [
    {
      "name": "Usa Laser Biotech, Inc.",
      "count": 6,
      "spellings": 1
    },
    {
      "name": "Cynosure, Inc.",
      "count": 4,
      "spellings": 1
    },
    {
      "name": "Dynatronics Corporation",
      "count": 4,
      "spellings": 1
    },
    {
      "name": "Escada International, Inc.",
      "count": 4,
      "spellings": 1
    },
    {
      "name": "Meditech International, Inc.",
      "count": 4,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Wuhan PHOMED Technology Company , Ltd.",
      "since": "2026-03-19",
      "kNumber": "K253965"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "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).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2162-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Wuhan PHOMED Technology Company , Ltd.",
        "recordIds": [
          "K253965"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 70 of 100 — 167 companies hold a clearance here and 1 arrived in the last 12 months",
        "recordIds": [
          "ILY:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AILY"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AILY"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AILY"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AILY"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AILY"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AILY"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AILY"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.711Z"
}