Alma Lasers Ltd.
⚠️ Moderate Risk
FEI: 3004167969 • Caesarea, Ha Zafon • ISRAEL
FEI Number
3004167969
Location
Caesarea, Ha Zafon
Country
ISRAELAddress
Industrial Park, Halamish St, Caesarea, 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
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/21/2023 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 10/22/2021 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/21/2016 | 79PKTLASER FOR DISRUPTION OF ADIPOCYTE CELLS FOR AESTHETIC USE | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Alma Lasers Ltd.'s FDA import refusal history?
Alma Lasers Ltd. (FEI: 3004167969) has 3 FDA import refusal record(s) in our database, spanning from 9/21/2016 to 11/21/2023.
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. Alma Lasers Ltd.'s FEI number is 3004167969.
What types of violations has Alma Lasers Ltd. received?
Alma Lasers Ltd. 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 Alma Lasers Ltd. come from?
All FDA import refusal data for Alma Lasers 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.