Universal Laser Systems
⚠️ High Risk
FEI: 1000135545 • Scottsdale, AZ • UNITED STATES
FEI Number
1000135545
Location
Scottsdale, AZ
Country
UNITED STATESAddress
16008 N 81st St, , Scottsdale, AZ, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/12/2025 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 11/6/2025 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 10/27/2025 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Universal Laser Systems's FDA import refusal history?
Universal Laser Systems (FEI: 1000135545) has 3 FDA import refusal record(s) in our database, spanning from 10/27/2025 to 11/12/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Universal Laser Systems's FEI number is 1000135545.
What types of violations has Universal Laser Systems received?
Universal Laser Systems has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Universal Laser Systems come from?
All FDA import refusal data for Universal Laser Systems is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.