FDA inspection

Laser Nova Ab: FDA inspection ending Jul 14, 2016

FDA inspection 982424 · Ostersund

Key facts

Inspection ID	982424
Firm	Laser Nova Ab
FEI number	3006151021
Address	Odenskogsvagen 1
City	Ostersund
Fiscal year	2016
Inspection end date	Jul 14, 2016
Project area	Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices
Product type	Devices

At a glance

1–9 Citations
1–9 Posted citations
No Warning letter followed
Yes Form FDA 483 issued
No Establishment inspection report (EIR) exists
1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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