Wicked Lasers
⚠️ Moderate Risk
FEI: 3008569929 • Quarry Bay, Hong Kong Island • HONG KONG
FEI Number
3008569929
Location
Quarry Bay, Hong Kong Island
Country
HONG KONGAddress
23/F, One Island East; 18 Westlands Road, Quarry Bay, Hong Kong Island, Hong Kong
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
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
Frequently Asked Questions
What is Wicked Lasers's FDA import refusal history?
Wicked Lasers (FEI: 3008569929) has 1 FDA import refusal record(s) in our database, spanning from 1/5/2012 to 1/5/2012.
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. Wicked Lasers's FEI number is 3008569929.
What types of violations has Wicked Lasers received?
Wicked Lasers has been cited for 2 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 Wicked Lasers come from?
All FDA import refusal data for Wicked Lasers 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.