Lensman
⚠️ Moderate Risk
FEI: 3010684966 • Gyeonggi-do • SOUTH KOREA
FEI Number
3010684966
Location
Gyeonggi-do
Country
SOUTH KOREAAddress
711 Mega 190-1 Skn Technopark, , Gyeonggi-do, , South Korea
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 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/15/2015 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/10/2015 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/1/2015 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/1/2015 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Lensman's FDA import refusal history?
Lensman (FEI: 3010684966) has 4 FDA import refusal record(s) in our database, spanning from 12/1/2015 to 12/15/2015.
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. Lensman's FEI number is 3010684966.
What types of violations has Lensman received?
Lensman 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 Lensman come from?
All FDA import refusal data for Lensman 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.