{
  "companyId": "54898",
  "slug": "cynosure-inc-54898",
  "name": "Cynosure, Inc.",
  "clearances": {
    "total": 108,
    "last12Months": 1,
    "first": "1992-07-08",
    "latest": "2026-06-17"
  },
  "medianReviewDays": 88,
  "productCodeCount": 10,
  "recalls": {
    "total": 1,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-0169-2015",
        "productCode": "GEX",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2014-10-09",
        "reason": "If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock"
      }
    ]
  },
  "registration": {
    "sites": 1,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "GEX",
      "deviceName": "Powered Laser Surgical Instrument",
      "clearances": 85,
      "latest": "2026-06-17",
      "medianReviewDays": 84
    },
    {
      "code": "PKT",
      "deviceName": "Laser For Disruption Of Adipocyte Cells For Aesthetic Use",
      "clearances": 6,
      "latest": "2019-01-03",
      "medianReviewDays": 97
    },
    {
      "code": "GEI",
      "deviceName": "Electrosurgical, Cutting & Coagulation & Accessories",
      "clearances": 5,
      "latest": "2022-11-23",
      "medianReviewDays": 128
    },
    {
      "code": "ILY",
      "deviceName": "Lamp, Infrared, Therapeutic Heating",
      "clearances": 4,
      "latest": "2013-05-02",
      "medianReviewDays": 108
    },
    {
      "code": "OHS",
      "deviceName": "Light Based Over The Counter Wrinkle Reduction",
      "clearances": 2,
      "latest": "2014-01-15",
      "medianReviewDays": 64
    },
    {
      "code": "OYW",
      "deviceName": "Laser, Cellulite Appearance",
      "clearances": 2,
      "latest": "2013-03-29",
      "medianReviewDays": 144
    },
    {
      "code": "FTC",
      "deviceName": "Light, Ultraviolet, Dermatological",
      "clearances": 1,
      "latest": "2005-05-05",
      "medianReviewDays": 112
    },
    {
      "code": "GAT",
      "deviceName": "Suture, Nonabsorbable, Synthetic, Polyethylene",
      "clearances": 1,
      "latest": "2023-07-06",
      "medianReviewDays": 132
    },
    {
      "code": "ISA",
      "deviceName": "Massager, Therapeutic, Electric",
      "clearances": 1,
      "latest": "2004-01-22",
      "medianReviewDays": 308
    },
    {
      "code": "PBX",
      "deviceName": "Massager, Vacuum, Radio Frequency Induced Heat",
      "clearances": 1,
      "latest": "2020-03-25",
      "medianReviewDays": 54
    }
  ],
  "productCodesShown": 10,
  "productCodesTotal": "10",
  "recentClearances": [
    {
      "kNumber": "K261570",
      "deviceName": "PICOSURE WORKSTATION",
      "productCode": "GEX",
      "decisionDate": "2026-06-17",
      "reviewDays": 36
    },
    {
      "kNumber": "K240396",
      "deviceName": "Elite iQ PRO (M122K1)",
      "productCode": "GEX",
      "decisionDate": "2024-03-08",
      "reviewDays": 29
    },
    {
      "kNumber": "K230510",
      "deviceName": "MyEllevate",
      "productCode": "GAT",
      "decisionDate": "2023-07-06",
      "reviewDays": 132
    },
    {
      "kNumber": "K223292",
      "deviceName": "TempSure System",
      "productCode": "GEI",
      "decisionDate": "2022-11-23",
      "reviewDays": 28
    },
    {
      "kNumber": "K212891",
      "deviceName": "TempSure System",
      "productCode": "GEI",
      "decisionDate": "2022-03-18",
      "reviewDays": 189
    },
    {
      "kNumber": "K210226",
      "deviceName": "PicoSure Workstation",
      "productCode": "GEX",
      "decisionDate": "2021-03-30",
      "reviewDays": 61
    },
    {
      "kNumber": "K200241",
      "deviceName": "TempSure System",
      "productCode": "PBX",
      "decisionDate": "2020-03-25",
      "reviewDays": 54
    },
    {
      "kNumber": "K193426",
      "deviceName": "Elite iQ",
      "productCode": "GEX",
      "decisionDate": "2020-03-09",
      "reviewDays": 90
    },
    {
      "kNumber": "K190678",
      "deviceName": "TempSure",
      "productCode": "GEI",
      "decisionDate": "2019-07-24",
      "reviewDays": 128
    },
    {
      "kNumber": "K182741",
      "deviceName": "SculpSure",
      "productCode": "PKT",
      "decisionDate": "2019-01-03",
      "reviewDays": 97
    }
  ],
  "nameVariants": {
    "total": "7",
    "shown": [
      {
        "name": "CYNOSURE, LLC",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Cynosure",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Cynosure, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Cynosure, Inc.",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Cynosure, Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Cynosure, Inc. Dba Ellman",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Cynosure, LLC",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Cynosure%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Cynosure%2C%20Inc.%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10
    }
  ],
  "retrievedAt": "2026-08-11T14:48:53.041Z"
}