FYLA LASER SL
⚠️ Moderate Risk
FEI: 3019964797 • Paterna, Valencia • SPAIN
FEI Number
3019964797
Location
Paterna, Valencia
Country
SPAINAddress
Calle Guglielmo Marconi 14, GUGLIELMO MARCONI 12, PARQUE TECNOLOGICO, Paterna, Valencia, Spain
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/18/2023 | 86HQFLASER, OPHTHALMIC | 237NO PMA | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is FYLA LASER SL's FDA import refusal history?
FYLA LASER SL (FEI: 3019964797) has 1 FDA import refusal record(s) in our database, spanning from 7/18/2023 to 7/18/2023.
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. FYLA LASER SL's FEI number is 3019964797.
What types of violations has FYLA LASER SL received?
FYLA LASER SL 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 FYLA LASER SL come from?
All FDA import refusal data for FYLA LASER SL 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.