# FDA 483 - Phoenix Thera-Lase Systems LLC - June 03, 2024

Source: https://www.keypedia.com/records/483/phoenix-thera-lase-systems-llc/e91130c9-2adf-441d-88f1-a14c5f1a822c

> FDA 483 for Phoenix Thera-Lase Systems LLC on June 03, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Phoenix Thera-Lase Systems LLC
- Inspection Date: 2024-06-03
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Phoenix Thera-Lase Systems LLC, a medical device specification developer in Dallas, TX, was cited for numerous significant quality system deficiencies during an FDA inspection. The firm lacked established procedures for critical areas such as design control, medical device reporting, nonconforming product, CAPA, complaints, process control, quality audits, management review, and training. Additionally, issues were noted with laser product certification, labeling, product reporting, and Unique Device Identifier (UDI) compliance for their Class IV Therapeutic Laser Systems.

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.keypedia.com/companies/phoenix-thera-lase-systems-llc/ec9f90b1-c32c-400d-b4eb-385829d68f9b

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