{
  "code": "FTC",
  "deviceName": "Light, Ultraviolet, Dermatological",
  "deviceClass": "II",
  "regulationNumber": "878.4630",
  "panel": "General, Plastic Surgery",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 272,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 21,
    "last12Months": 7
  },
  "reviewDays": {
    "median": 43,
    "sampleSize": 272
  },
  "recalls": {
    "total": 15,
    "recent": [
      {
        "resNumber": "Z-2742-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Daavlin Distributing Company",
        "firmAsPublished": "Daavlin Distributing Company",
        "reason": "Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be \"4/5\" instead of \"7\" (counts were at ~1000 instead of ~5000).",
        "initiated": "2026-03-05"
      },
      {
        "resNumber": "Z-2743-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Daavlin Distributing Company",
        "firmAsPublished": "Daavlin Distributing Company",
        "reason": "Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be \"4/5\" instead of \"7\" (counts were at ~1000 instead of ~5000).",
        "initiated": "2026-03-05"
      },
      {
        "resNumber": "Z-2744-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Daavlin Distributing Company",
        "firmAsPublished": "Daavlin Distributing Company",
        "reason": "Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be \"4/5\" instead of \"7\" (counts were at ~1000 instead of ~5000).",
        "initiated": "2026-03-05"
      },
      {
        "resNumber": "Z-2295-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Daavlin Distributing Company",
        "firmAsPublished": "Daavlin Distributing Company",
        "reason": "Some of the Calibration/Output Certificates had the outputs reversed.",
        "initiated": "2025-12-10"
      },
      {
        "resNumber": "Z-1073-2022",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Daavlin Distributing Company",
        "firmAsPublished": "Daavlin Distributing Company",
        "reason": "Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0\" inches to \"9. Resulting in over or under dosing.",
        "initiated": "2022-04-26"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K254234",
      "deviceName": "Phototherapy System (DUV-COMBO)",
      "applicant": "Choyang Medics Co., Ltd.",
      "company": "Choyang Medics Co., Ltd.",
      "decisionDate": "2026-05-01",
      "dateReceived": "2025-12-29"
    },
    {
      "kNumber": "K253871",
      "deviceName": "Klär Lite (RCW-KL1000)",
      "applicant": "Radcliffe Watts, LLC",
      "company": "Radcliffe Watts, LLC",
      "decisionDate": "2026-03-04",
      "dateReceived": "2025-12-04"
    },
    {
      "kNumber": "K250425",
      "deviceName": "Ultraviolet Phototherapy Device",
      "applicant": "APK Technology Co., Ltd.",
      "company": "APK Technology Co., Ltd.",
      "decisionDate": "2025-04-07",
      "dateReceived": "2025-02-14"
    },
    {
      "kNumber": "K244022",
      "deviceName": "308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)",
      "applicant": "Boston Aesthetics, Inc.",
      "company": "Boston Aesthetics, Inc.",
      "decisionDate": "2025-03-13",
      "dateReceived": "2024-12-27"
    },
    {
      "kNumber": "K242977",
      "deviceName": "308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)",
      "applicant": "Xuzhou Kernel Medical Equipment Co., Ltd.",
      "company": "Xuzhou Kernel Medical Equipment Co., Ltd.",
      "decisionDate": "2025-02-06",
      "dateReceived": "2024-09-26"
    },
    {
      "kNumber": "K242908",
      "deviceName": "UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)",
      "applicant": "Shanghai Sigma High-Tech Co., Ltd.",
      "company": "Shanghai Sigma High-Tech Co., Ltd.",
      "decisionDate": "2024-12-19",
      "dateReceived": "2024-09-24"
    },
    {
      "kNumber": "K233811",
      "deviceName": "DT Controlled Phototherapy Equipment",
      "applicant": "Daavlin Distributing Co.",
      "company": "Daavlin Distributing Company",
      "decisionDate": "2023-12-13",
      "dateReceived": "2023-11-29"
    },
    {
      "kNumber": "K223882",
      "deviceName": "Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)",
      "applicant": "Shenzhen Honpal Optoelectronic Technology Co., Ltd.",
      "company": "Shenzhen Honpal Optoelectronic Technology Co., Ltd.",
      "decisionDate": "2023-03-27",
      "dateReceived": "2022-12-27"
    },
    {
      "kNumber": "K230382",
      "deviceName": "3 Series NeoLux",
      "applicant": "Daavlin Distributing Co.",
      "company": "Daavlin Distributing Company",
      "decisionDate": "2023-03-24",
      "dateReceived": "2023-02-13"
    },
    {
      "kNumber": "K230076",
      "deviceName": "Enhanced AURORA™ Medical Diode System, and related accessories",
      "applicant": "Psoria-Shield, Inc.",
      "company": "Psoria-Shield, Inc.",
      "decisionDate": "2023-03-08",
      "dateReceived": "2023-01-10"
    }
  ],
  "topApplicants": [
    {
      "name": "National Biological Corp.",
      "count": 26
    },
    {
      "name": "Daavlin Distributing Co.",
      "count": 14
    },
    {
      "name": "Philips Int'L B.V.",
      "count": 9
    },
    {
      "name": "Light Sources, Inc.",
      "count": 8
    },
    {
      "name": "Mottek Intl. Corp.",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "National Biological Corp",
      "count": 27,
      "spellings": 2
    },
    {
      "name": "Daavlin Distributing Company",
      "count": 16,
      "spellings": 2
    },
    {
      "name": "Philips Int'L B.V.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Light Sources, Inc.",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "Mottek Intl. Corp.",
      "count": 8,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Choyang Medics Co., Ltd.",
      "since": "2026-05-01",
      "kNumber": "K254234"
    },
    {
      "name": "Radcliffe Watts, LLC",
      "since": "2026-03-04",
      "kNumber": "K253871"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "FTC (Light, Ultraviolet, Dermatological) has three findings, most consequential first. 4 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2742-2026, Z-2743-2026, Z-2744-2026, Z-2295-2026). 2 first-time filers in the last 12 months, Choyang Medics Co., Ltd. and Radcliffe Watts, LLC (K254234, K253871). The code is crowded, scoring 75 of 100 — 143 companies hold a clearance here and 2 arrived in the last 12 months (FTC:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "4 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2742-2026",
          "Z-2743-2026",
          "Z-2744-2026",
          "Z-2295-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, Choyang Medics Co., Ltd. and Radcliffe Watts, LLC",
        "recordIds": [
          "K254234",
          "K253871"
        ],
        "severity": 42
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 75 of 100 — 143 companies hold a clearance here and 2 arrived in the last 12 months",
        "recordIds": [
          "FTC: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%3AFTC"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFTC"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFTC"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AFTC"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AFTC"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AFTC"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AFTC"
    }
  ],
  "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": "2026-08-11T13:51:45.698Z"
}