{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "87683",
      "product_res_number": "Z-0587-2010",
      "event_date_initiated": "2008-08-08",
      "event_date_posted": "2010-01-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-05-25",
      "res_event_number": "54153",
      "product_code": "NVK",
      "product_description": "SoftLase Pro Dental Lasers:  Zap SoftLase, SoftLase Pro, OrthoLase, and HygieneLase models, Model numbers ZA-SLP, ZA-ORT, ZA-HYG, G22002SLP, ZA-SOFTLASE2WSII, ZA-SOFTLASER2W, Manufactured by Zap Lasers LLC, Pleasant Hill, CA.\n\nIntended use: Dentistry.",
      "code_info": "All SoftLase Pro Dental Lasers.",
      "firm_fei_number": "3005212363",
      "recalling_firm": "Zap Lasers LLC",
      "address_1": "2621 Pleasant Hill Rd Ste B 2621 Pleasant Hill Rd",
      "address_2": "Ste B",
      "city": "Pleasant Hill",
      "state": "CA",
      "postal_code": "94523-2161",
      "additional_info_contact": "925-930-6725",
      "reason_for_recall": "The SoftLase Lasers are in need of compliance upgrades due to lack of a remote interlock connector, an emission delay, user guide labels and locations, and calibration procedures and schedule.",
      "root_cause_description": "Radiation Control for Health and Safety Act",
      "action": "Zap Lasers sent a letter to affectedcustomers stating that their SoftLase diode laser is eligible for a compliance maintenance upgrade.  The upgrades will be free of charge and will enhance the safety of the laser.  Customers are encouraged to call the firm's customer service line at 888-876-4547 to schedule their RMA number and shipping instructions.  The letter also lists the upgrades that are needed.",
      "product_quantity": "1375 units",
      "distribution_pattern": "Worldwide Distribution to 1397 consignees",
      "openfda": {
        "k_number": [
          "K210367",
          "K213428",
          "K221761",
          "K250731",
          "K232885",
          "K243764",
          "K213658",
          "K232222",
          "K230047",
          "K203396",
          "K260765",
          "K030146",
          "K253309",
          "K201387",
          "K211150",
          "K210350",
          "K214008"
        ],
        "device_name": "Laser, Dental, Soft Tissue",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4810",
        "device_class": "2",
        "registration_number": [
          "3030090167",
          "3005581016",
          "1032227",
          "3017181358",
          "3001431138",
          "3017125161",
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          "2916735",
          "9613462",
          "1000548922",
          "3011877721",
          "3005515469",
          "3004475754",
          "1419489"
        ],
        "fei_number": [
          "3003258642",
          "3030090167",
          "3005581016",
          "1000597018",
          "1032227",
          "3017181358",
          "3001431138",
          "3017125161",
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          "2027755",
          "3010175098",
          "3018318562",
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          "2916735",
          "1000548922",
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          "3005515469",
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          "1419489"
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      }
    }
  ]
}