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

Source: https://www.keypedia.com/records/483/phoenix-thera-lase-systems-llc/1e68142d-8437-4d41-9cf8-44a2835101ab

> FDA 483 for Phoenix Thera-Lase Systems LLC on June 03, 2024. Product: devices. 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: devices
- Office Name: Dallas District Office
- Summary: Phoenix Thera-Lase Systems LLC, a medical device specification developer, underwent an FDA inspection from May 22 to June 3, 2024. The inspection identified 18 observations, indicating broad non-compliance with federal regulations for medical devices and electronic product radiation control.

Key violations included the absence or inadequacy of crucial quality system procedures for their Class IV Therapeutic Laser Systems. Specifically, the company lacked established design control procedures, could not provide design history files, and had insufficient processes for medical device reporting (MDRs) of adverse events and malfunctions. There were no procedures for controlling nonconforming products, managing corrective and preventive actions (CAPA), or handling customer complaints effectively. Additionally, the firm failed to establish process controls for its repackaging and relabeling operations.

Significant issues also arose regarding product certification and labeling. Phoenix Thera-Lase Systems could not provide documentation of laser product certification or quality control procedures for radiation safety. Their Class IV laser systems were distributed without required certification, identification, and DANGER labels, and the DANGER logotype did not meet regulatory specifications. Required product reports were not submitted to the FDA, and the company had not registered its Class IV laser system with the Global Unique Device Identification Database (GUDID), nor did its devices bear appropriate Unique Device Identifier (UDI) labeling.

Furthermore, essential quality management components were deficient, with no established procedures or records for quality audits, management reviews (except for a recent one), or adequate employee training. To achieve compliance, Phoenix Thera-Lase Systems LLC must promptly develop, implement, and document robust quality system procedures for all identified areas, ensuring full adherence to all applicable federal regulations to safeguard public health and product quality.

## 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/fa067915-5156-4949-839a-ed1b57c356de

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9