# FDA 483 - Lumanosity Inc - August 24, 2018

Source: https://www.keypedia.com/records/483/lumanosity-inc/5d6449d2-c611-4861-9fcd-4e115ac28536

> FDA 483 for Lumanosity Inc on August 24, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lumanosity Inc
- Inspection Date: 2018-08-24
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/lumanosity-inc/573b2c5e-4046-47e0-aa8b-c68f421b7c28

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6