{
  "code": "GEX",
  "deviceName": "Powered Laser Surgical Instrument",
  "deviceClass": "II",
  "regulationNumber": "878.4810",
  "panel": "General, Plastic Surgery",
  "definition": "A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810  describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 2872,
    "last12Months": 73
  },
  "adverseEvents": {
    "total": 7316,
    "last12Months": 1755
  },
  "reviewDays": {
    "median": 90,
    "sampleSize": 2872
  },
  "recalls": {
    "total": 200,
    "recent": [
      {
        "resNumber": "Z-2554-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "IPG Medical Corporation",
        "firmAsPublished": "IPG Medical Corporation",
        "reason": "Software anomaly that causes a false display of error code 5018.",
        "initiated": "2026-05-05"
      },
      {
        "resNumber": "Z-1694-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Olympus Corporation of the Americas",
        "firmAsPublished": "Olympus Corporation of the Americas",
        "reason": "Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.",
        "initiated": "2026-02-27"
      },
      {
        "resNumber": "Z-1695-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Olympus Corporation of the Americas",
        "firmAsPublished": "Olympus Corporation of the Americas",
        "reason": "Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.",
        "initiated": "2026-02-27"
      },
      {
        "resNumber": "Z-1558-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Lutronic Corporation",
        "firmAsPublished": "Lutronic Corporation",
        "reason": "Reports of devices sparking/popping and potentially burning patients.",
        "initiated": "2026-01-27"
      },
      {
        "resNumber": "Z-1130-2026",
        "status": "Completed",
        "recallClass": "Class II",
        "firm": "LEASEIR TECHNOLOGIES SLU",
        "firmAsPublished": "LEASEIR TECHNOLOGIES SLU",
        "reason": "The console label for affected devices is missing the \"DANGER\" symbol.",
        "initiated": "2025-12-15"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261221",
      "deviceName": "SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)",
      "applicant": "Olympus Surgical Technologies America",
      "company": "Olympus Surgical Technologies America",
      "decisionDate": "2026-07-24",
      "dateReceived": "2026-04-14"
    },
    {
      "kNumber": "K261738",
      "deviceName": "Medical Thulium Fiber Laser Systems (UroFiber 150Q)",
      "applicant": "Rhein Laser Technologies Co., Ltd.",
      "company": "Rhein Laser Technologies Co., Ltd.",
      "decisionDate": "2026-07-21",
      "dateReceived": "2026-05-27"
    },
    {
      "kNumber": "K261693",
      "deviceName": "Diode laser hair removal machine (QDTM-04)",
      "applicant": "Beijing Nubway S&T Co., Ltd.",
      "company": "Beijing Nubway S&T Co., Ltd.",
      "decisionDate": "2026-07-17",
      "dateReceived": "2026-05-22"
    },
    {
      "kNumber": "K261674",
      "deviceName": "Skin Air Cooling System (QALF-01)",
      "applicant": "Beijing Nubway S&T Co., Ltd.",
      "company": "Beijing Nubway S&T Co., Ltd.",
      "decisionDate": "2026-07-16",
      "dateReceived": "2026-05-21"
    },
    {
      "kNumber": "K261701",
      "deviceName": "Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)",
      "applicant": "Micro-Energy Medical Technology Co., Ltd.",
      "company": "Micro-Energy Medical Technology Co., Ltd.",
      "decisionDate": "2026-06-18",
      "dateReceived": "2026-05-22"
    },
    {
      "kNumber": "K261570",
      "deviceName": "PICOSURE WORKSTATION",
      "applicant": "Cynosure, LLC",
      "company": "Cynosure, Inc.",
      "decisionDate": "2026-06-17",
      "dateReceived": "2026-05-12"
    },
    {
      "kNumber": "K260690",
      "deviceName": "LumiGlam Laser System (SHE-LSP601-3)",
      "applicant": "Beijing Sano Laser S&T Development Co.,Ltd",
      "company": "Beijing Sano Laser S&T Development Co, Ltd.",
      "decisionDate": "2026-06-04",
      "dateReceived": "2026-03-03"
    },
    {
      "kNumber": "K260489",
      "deviceName": "LASEmaR 1500",
      "applicant": "Eufoton S.R.L.",
      "company": "Eufoton S.R.L.",
      "decisionDate": "2026-05-29",
      "dateReceived": "2026-02-13"
    },
    {
      "kNumber": "K260138",
      "deviceName": "LUNE PureHygiene",
      "applicant": "Enamel Pure",
      "company": "Enamel Pure Inc.",
      "decisionDate": "2026-05-29",
      "dateReceived": "2026-01-16"
    },
    {
      "kNumber": "K253245",
      "deviceName": "Boston 2910 (Boston 2910)",
      "applicant": "Boston Aesthetics, Inc.",
      "company": "Boston Aesthetics, Inc.",
      "decisionDate": "2026-05-21",
      "dateReceived": "2025-09-29"
    }
  ],
  "topApplicants": [
    {
      "name": "Cynosure, Inc.",
      "count": 80
    },
    {
      "name": "Sharplan Lasers, Inc.",
      "count": 66
    },
    {
      "name": "Quanta System Spa",
      "count": 57
    },
    {
      "name": "Laserscope",
      "count": 49
    },
    {
      "name": "Trimedyne, Inc.",
      "count": 48
    }
  ],
  "topCompanies": [
    {
      "name": "Cynosure, Inc.",
      "count": 85,
      "spellings": 3
    },
    {
      "name": "Sharplan Lasers, Inc.",
      "count": 66,
      "spellings": 1
    },
    {
      "name": "Lumenis, Inc.",
      "count": 60,
      "spellings": 3
    },
    {
      "name": "Quanta System Spa",
      "count": 57,
      "spellings": 1
    },
    {
      "name": "Candela Corporation",
      "count": 53,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Haidari Beauty Technology (Beijing) Co., Ltd.",
      "since": "2026-03-03",
      "kNumber": "K253920"
    },
    {
      "name": "ORO Co., Ltd.",
      "since": "2026-02-26",
      "kNumber": "K254271"
    },
    {
      "name": "Xi'An Taibo Electronic Technology Co., Ltd.",
      "since": "2026-02-03",
      "kNumber": "K252048"
    },
    {
      "name": "Boston Aesthetics, Inc.",
      "since": "2026-01-21",
      "kNumber": "K252369"
    },
    {
      "name": "Speclipse, Inc.",
      "since": "2025-11-25",
      "kNumber": "K253344"
    },
    {
      "name": "Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.",
      "since": "2025-11-20",
      "kNumber": "K253007"
    },
    {
      "name": "Classys, Inc.",
      "since": "2025-11-20",
      "kNumber": "K253123"
    },
    {
      "name": "Baoding Te'Anzhou Electronic Technology Co., Ltd.",
      "since": "2025-11-07",
      "kNumber": "K252564"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 141,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 218,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 237,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 183,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 190,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 192,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 175,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 191,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 149,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 154,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 168,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 178,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 171,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 184,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 242,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 178,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 196,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 168,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 174,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 201,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 201,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 148,
        "expectedLow": 117.99675060295246,
        "expectedHigh": 230.5514596796982,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 197,
        "expectedLow": 95.97208787537129,
        "expectedHigh": 194.27895522331633,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 200,
        "expectedLow": 118.35339634947995,
        "expectedHigh": 241.6547096646311,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 224,
        "expectedLow": 126.75715845988248,
        "expectedHigh": 257.5625388454945,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 240,
        "expectedLow": 124.23654664217234,
        "expectedHigh": 254.0682021372024,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 249,
        "expectedLow": 136.26786234321708,
        "expectedHigh": 289.7833610514561,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 265,
        "expectedLow": 229.5300171417568,
        "expectedHigh": 470.10691481178833,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 253,
        "expectedLow": 157.07328131978178,
        "expectedHigh": 333.79318129078376,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 220,
        "expectedLow": 167.41749492992153,
        "expectedHigh": 353.2949638152519,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 266,
        "expectedLow": 158.49505696613406,
        "expectedHigh": 334.5613548003322,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 214,
        "expectedLow": 155.85248545445702,
        "expectedHigh": 300.1159593071859,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 219,
        "expectedLow": 168.8962550691137,
        "expectedHigh": 326.878621278984,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 191,
        "expectedLow": 184.37593315181047,
        "expectedHigh": 366.4264373542065,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 226,
        "expectedLow": 131.02055935451236,
        "expectedHigh": 294.64440323142406,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 236,
        "expectedLow": 148.755408039647,
        "expectedHigh": 325.80929120529936,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "GEX (Powered Laser Surgical Instrument) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2554-2026, Z-1694-2026, Z-1695-2026, Z-1558-2026, Z-1130-2026). 18 first-time filers in the last 12 months, including Haidari Beauty Technology (Beijing) Co., Ltd. and ORO Co., Ltd (K253920, K254271, K252048, K252369, K253344). The code is crowded, scoring 100 of 100 — 742 companies hold a clearance here and 73 arrived in the last 12 months (GEX:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2554-2026",
          "Z-1694-2026",
          "Z-1695-2026",
          "Z-1558-2026",
          "Z-1130-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "18 first-time filers in the last 12 months, including Haidari Beauty Technology (Beijing) Co., Ltd. and ORO Co., Ltd.",
        "recordIds": [
          "K253920",
          "K254271",
          "K252048",
          "K252369",
          "K253344"
        ],
        "severity": 50
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 100 of 100 — 742 companies hold a clearance here and 73 arrived in the last 12 months",
        "recordIds": [
          "GEX: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%3AGEX"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGEX"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGEX"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AGEX"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AGEX"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AGEX"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AGEX"
    }
  ],
  "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": "2026-08-11T13:51:45.703Z"
}