Lensmam Co. Ltd
⚠️ High Risk
FEI: 3009321484 • Gyeonggi-do, Seongnam-si • SOUTH KOREA
FEI Number
3009321484
Location
Gyeonggi-do, Seongnam-si
Country
SOUTH KOREAAddress
Rm. 304 & 305. Pos Techno. Sangdaewon 1-, dong, Jungwon-gu, Seongnam-si, Gyeonggi-do, Seongnam-si, South Korea
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 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.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/4/2023 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/3/2020 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of Southeast Imports (DSEI) | |
| 12/21/2018 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 1/4/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 4/5/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 2/5/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 1/6/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/17/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/17/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/17/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/17/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/17/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/17/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/17/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/16/2015 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/15/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/15/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/15/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/15/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/15/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/15/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/15/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/15/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/15/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/15/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/15/2015 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/15/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/15/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/15/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/15/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/15/2015 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/15/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/10/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/10/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/10/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/10/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/10/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/10/2015 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/10/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/10/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/10/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/10/2015 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/10/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/10/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/10/2015 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/10/2015 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/10/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/10/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/10/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/10/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/10/2015 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/10/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/8/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/8/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/2/2015 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/2/2015 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/2/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/2/2015 | 86LYLACCESSORIES TO CONTACT LENS SOLUTION | New York District Office (NYK-DO) | |
| 12/1/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/1/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/1/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/1/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/1/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/1/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 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 | 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 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/1/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/30/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/30/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/30/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/30/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/30/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/30/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/30/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/30/2015 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/30/2015 | 86MZDSYSTEM, IN-OFFICE TINTING, CONTACT LENSES | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/30/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/30/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/30/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/30/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/30/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/30/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/24/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New York District Office (NYK-DO) | |
| 11/23/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New York District Office (NYK-DO) | |
| 11/23/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New York District Office (NYK-DO) | |
| 11/23/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New York District Office (NYK-DO) | |
| 11/23/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New York District Office (NYK-DO) | |
| 11/23/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New York District Office (NYK-DO) | |
| 11/23/2015 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | New York District Office (NYK-DO) | |
| 11/20/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | New York District Office (NYK-DO) | |
| 11/19/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/19/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/17/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/17/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New York District Office (NYK-DO) |
| 11/13/2015 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | New York District Office (NYK-DO) |
| 3/31/2014 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Lensmam Co. Ltd's FDA import refusal history?
Lensmam Co. Ltd (FEI: 3009321484) has 98 FDA import refusal record(s) in our database, spanning from 3/31/2014 to 12/4/2023.
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. Lensmam Co. Ltd's FEI number is 3009321484.
What types of violations has Lensmam Co. Ltd received?
Lensmam Co. Ltd has been cited for 6 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 Lensmam Co. Ltd come from?
All FDA import refusal data for Lensmam Co. Ltd 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.