LUMENIS, LTD.
⚠️ Moderate Risk
FEI: 3004135191 • Yokne'Am Ilit, Ha Zafon • ISRAEL
FEI Number
3004135191
Location
Yokne'Am Ilit, Ha Zafon
Country
ISRAELAddress
Yokneam Ind. Park, 6, Ha-Kidma, Yokne'Am Ilit, Ha Zafon, Israel
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
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.
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).
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.
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.
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.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/7/2023 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Southeast Imports (DSEI) | |
| 11/1/2022 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 12/17/2021 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Southeast Imports (DSEI) | |
| 5/26/2021 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of West Coast Imports (DWCI) | |
| 6/24/2019 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Southeast Imports (DSEI) | |
| 4/9/2019 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Southeast Imports (DSEI) | |
| 10/4/2013 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is LUMENIS, LTD.'s FDA import refusal history?
LUMENIS, LTD. (FEI: 3004135191) has 7 FDA import refusal record(s) in our database, spanning from 10/4/2013 to 3/7/2023.
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. LUMENIS, LTD.'s FEI number is 3004135191.
What types of violations has LUMENIS, LTD. received?
LUMENIS, LTD. has been cited for 9 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 LUMENIS, LTD. come from?
All FDA import refusal data for LUMENIS, 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.