Lumanosity IncAugust 24, 2018

FDA 483 - Lumanosity Inc - August 24, 2018

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Record Details

Lumanosity Inc, a medical device manufacturer in San Diego, CA, was inspected by the FDA and received a Form 483 with two observations. The inspection revealed a lack of established procedures for design control and device history records for their Class II Infrared Light Therapy medical device.

Company: Lumanosity Inc
Inspection Date: August 24, 2018
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Sarah A. Hassas (investigator)

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ID · 5d6449d2-c611-4861-9fcd-4e115ac28536