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Sz Lightlaser Science And Tech

✅ Low Risk

FEI: 3010003168 • Hongkong • HONG KONG

FEI

FEI Number

3010003168

📍

Location

Hongkong

🇭🇰

Country

HONG KONG
🏢

Address

No 3 Bai Shun Industrial Area, , Hongkong, , Hong Kong

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
5
Unique Violations
2/25/2013
Latest Refusal
2/25/2013
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

2781×

NO TAG

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 to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

3441×

WARNINGS

It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.

471×

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

DateProductViolationsDivision
2/25/2013
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
278NO TAG
333LACKS FIRM
336INCONSPICU
344WARNINGS
47NON STD
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Sz Lightlaser Science And Tech's FDA import refusal history?

Sz Lightlaser Science And Tech (FEI: 3010003168) has 1 FDA import refusal record(s) in our database, spanning from 2/25/2013 to 2/25/2013.

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. Sz Lightlaser Science And Tech's FEI number is 3010003168.

What types of violations has Sz Lightlaser Science And Tech received?

Sz Lightlaser Science And Tech has been cited for 5 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 Sz Lightlaser Science And Tech come from?

All FDA import refusal data for Sz Lightlaser Science And Tech 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.