FDA applicant

Phoenix Thera-Lase Systems, LLC

Dallas, TX1 decision2015–20150 recalls

FDA records 1 decision for Phoenix Thera-Lase Systems, LLC (Dallas, TX) in 2015: 1 510(k) clearance. All are in product code ILY (Lamp, Infrared, Therapeutic Heating). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Phoenix Thera-Lase Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Phoenix Thera-Lase Systems, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Phoenix Thera-Lase Systems, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Phoenix”

FDA records each applicant name separately; these may or may not be the same firm.

Phoenix Diagnostics, Inc. 21 Phoenix Biomedical Corp. 13 Phoenix Medical Technology, Inc. 11 Phoenix Glove Co. 6 Phoenix Dental, Inc. 5 Phoenix Bioengineering, Inc. 3 Phoenix Medical Devices, LLC 2 Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. 2 Phoenix Biotech Corp. 2 Phoenix Imaging 2 Phoenix Surgical Products, Inc. 1 Phoenix Management, Inc. 1

Phoenix Thera-Lase Systems, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Phoenix”