# FDA 483 - CureWave Lasers, LLC - August 05, 2021

Source: https://www.globalkeysolutions.net/records/483/curewave-lasers-llc/205160d4-9601-429c-9242-fc8dd6ba120a

> FDA 483 for CureWave Lasers, LLC on August 05, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CureWave Lasers, LLC
- Inspection Date: 2021-08-05
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Curewave Lasers LLC, a medical device manufacturer in Dallas, TX, was inspected by the FDA, resulting in seven observations, many of which were repeat findings. The inspection revealed significant deficiencies in product certification, laser radiation measurement, calibration procedures, labeling, equipment maintenance, supplier control, and document control for their Class IV laser medical device, Medicor. These issues indicate a systemic lack of adherence to quality system requirements and performance standards.

## Related Documents

- [483 - 2019-09-05](https://www.globalkeysolutions.net/records/483/curewave-lasers-llc/995e6808-5c79-4dcd-a499-52c55f0bced5)

## Related Officers

- [Jocelyn C. Turner](https://www.globalkeysolutions.net/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.globalkeysolutions.net/companies/curewave-lasers-llc/939f154a-b009-4fe1-b6c0-fb834e7fb3fe

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab