{
  "format": "devicerts.device.v1",
  "cite_as": "LENSAR Femtosecond Laser System, Lensar, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/lensar-laser-system-ooe (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/lensar-laser-system-ooe",
    "json_url": "https://devicerts.com/devices/lensar-laser-system-ooe.json",
    "markdown_url": "https://devicerts.com/devices/lensar-laser-system-ooe.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-06",
    "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/devices/lensar-laser-system-ooe",
    "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."
  },
  "device": {
    "name": "LENSAR Femtosecond Laser System",
    "registry_name": "LENSAR LASER SYSTEM",
    "url": "https://devicerts.com/devices/lensar-laser-system-ooe",
    "manufacturer": {
      "name": "Lensar, Inc.",
      "url": "https://devicerts.com/manufacturers/lensar",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K090633",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "OOE"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The LENSAR Femtosecond Laser System is an ophthalmic femtosecond laser designed for refractive cataract surgery. It performs precise laser capsulotomies, lens fragmentation, limbal relaxing incisions, and corneal incisions, enabling multiple procedures in a single session with high accuracy.\n\nThis device is intended for use in clinical settings by ophthalmic surgeons and is supplied as a reusable medical instrument. It has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device (OOE). The system is not single-use and does not require sterile packaging, though proper cleaning and maintenance protocols must be followed. No specific MRI safety information is provided in the data.",
      "ai_generated": true,
      "generated_on": "2026-09-19",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K090633",
      "number_label": null,
      "device_udi_di": null,
      "date": "2010-05-13",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K090633",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "OOE",
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            }
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    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
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            {
              "value": "Class II",
              "registries": [
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            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 886.4390",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Ophthalmic",
              "registries": [
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            }
          ]
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            {
              "value": "SESE",
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            }
          ]
        }
      ]
    }
  ]
}