{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Lensar. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/lensar (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/lensar",
    "json_url": "https://devicerts.com/manufacturers/lensar.json",
    "markdown_url": "https://devicerts.com/manufacturers/lensar.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-14",
    "status_as_of": "2026-11-14",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/manufacturers/lensar",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "manufacturer": {
    "name": "Lensar",
    "url": "https://devicerts.com/manufacturers/lensar",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "LENSAR, Inc"
    ],
    "country": "United States",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "US-MF-000008522"
      }
    ],
    "summary": "Lensar is a medical device manufacturer based in the United States, with 17 devices listed in FDA 510(k), FDA GUDID and EUDAMED (FDA Class II; EU Class IIb) as of 14 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 17,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA 510(k)",
        "devices": 10
      },
      {
        "registry": "FDA GUDID",
        "devices": 7
      },
      {
        "registry": "EUDAMED",
        "devices": 5
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 12
      },
      {
        "class": "EU Class IIb",
        "devices": 5
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Z12",
        "name": "Instruments for functional explorations and therapeutic interventions",
        "url": "https://devicerts.com/categories/emdn/Z12",
        "devices": 5
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "Emergo Europe B.V.",
        "url": "https://devicerts.com/representatives/emergo-europe-bv-nl-ar-000000116",
        "country": "Netherlands"
      }
    ]
  },
  "devices": {
    "shown": 17,
    "total": 17,
    "all_devices_url": "https://devicerts.com/manufacturers/lensar",
    "items": [
      {
        "name": "LENSAR LLS-fs 3D 70-00013-001",
        "url": "https://devicerts.com/devices/lensar-lls-fs-3d-70-00013-001",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LENSAR LLS-fs 3D 70-00005-001",
        "url": "https://devicerts.com/devices/lensar-lls-fs-3d-70-00005-001",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Patient Interface Device",
        "url": "https://devicerts.com/devices/patient-interface-device-70-00044-001",
        "model_reference": "70-00044-001",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Patient Interface Device",
        "url": "https://devicerts.com/devices/patient-interface-device-70-00046-001",
        "model_reference": "70-00046-001",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Patient Interface Device",
        "url": "https://devicerts.com/devices/patient-interface-device-70-00036-001",
        "model_reference": "70-00036-001",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lensar Laser System - Fs 3D For Corneal Incisions",
        "url": "https://devicerts.com/devices/lensar-laser-system-fs-3d-for-corneal-incisions-hqc",
        "model_reference": "K122829",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2012-12-03",
        "open_recall": false
      },
      {
        "name": "LENSAR Laser System - fs 3D (LLS-fs 3D)",
        "url": "https://devicerts.com/devices/lensar-laser-system-fs-3d-lls-fs-3d-ooe-k152453",
        "model_reference": "K152453",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2015-10-15",
        "open_recall": false
      },
      {
        "name": "LENSAR Laser System - fs 3D (LLS-fs 3D)",
        "url": "https://devicerts.com/devices/lensar-laser-system-fs-3d-lls-fs-3d-ooe-k181430",
        "model_reference": "K181430",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2018-08-09",
        "open_recall": false
      },
      {
        "name": "LENSAR Laser System - fs 3D (LLS-fs 3D)",
        "url": "https://devicerts.com/devices/lensar-laser-system-fs-3d-lls-fs-3d-ooe-k173346",
        "model_reference": "K173346",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2018-03-02",
        "open_recall": false
      },
      {
        "name": "Lensar Laser System",
        "url": "https://devicerts.com/devices/lensar-laser-system-ooe",
        "model_reference": "K090633",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2010-05-13",
        "open_recall": false
      },
      {
        "name": "LENSAR Laser System - fs 3D",
        "url": "https://devicerts.com/devices/lensar-laser-system-fs-3d-ooe",
        "model_reference": "K143010",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2015-03-20",
        "open_recall": false
      },
      {
        "name": "LENSAR Laser System – fs 3D (LLS-fs 3D)",
        "url": "https://devicerts.com/devices/lensar-laser-system-fs-3d-lls-fs-3d-ooe-k171337",
        "model_reference": "K171337",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2017-08-10",
        "open_recall": false
      },
      {
        "name": "Lensar Laser System For Anterior Capsulotomy",
        "url": "https://devicerts.com/devices/lensar-laser-system-for-anterior-capsulotomy-ooe",
        "model_reference": "K102727",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2011-03-16",
        "open_recall": false
      },
      {
        "name": "LENSAR Laser System - fs 3D (LLS-fs 3D)",
        "url": "https://devicerts.com/devices/lensar-laser-system-fs-3d-lls-fs-3d-ooe-k182795",
        "model_reference": "K182795",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2018-12-21",
        "open_recall": false
      },
      {
        "name": "LENSAR Laser System - fs 3D (LLS-fs 3D)",
        "url": "https://devicerts.com/devices/lensar-laser-system-fs-3d-lls-fs-3d-ooe",
        "model_reference": "K170576",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2017-05-05",
        "open_recall": false
      },
      {
        "name": "ALLY Drapes",
        "url": "https://devicerts.com/devices/ally-drapes-70-00055-001",
        "model_reference": "70-00055-001",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ALLY Adaptive Cataract Treatment System",
        "url": "https://devicerts.com/devices/ally-adaptive-cataract-treatment-system-70-00050-001",
        "model_reference": "70-00050-001",
        "device_class": "Class IIb",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}