Radiancy (Israel) Ltd.
⚠️ Moderate Risk
FEI: 3007567374 • Hod ha-Sharon • ISRAEL
FEI Number
3007567374
Location
Hod ha-Sharon
Country
ISRAELAddress
5, Ha-Nagar, , Hod ha-Sharon, , 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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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).
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 |
|---|---|---|---|
| 7/20/2015 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Cincinnati District Office (CIN-DO) | |
| 2/5/2014 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Cincinnati District Office (CIN-DO) | |
| 3/1/2012 | 79OLPOVER-THE-COUNTER POWERED RED/BLUE LIGHT BASED LASER FOR ACNE | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 3/1/2012 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Radiancy (Israel) Ltd.'s FDA import refusal history?
Radiancy (Israel) Ltd. (FEI: 3007567374) has 4 FDA import refusal record(s) in our database, spanning from 3/1/2012 to 7/20/2015.
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. Radiancy (Israel) Ltd.'s FEI number is 3007567374.
What types of violations has Radiancy (Israel) Ltd. received?
Radiancy (Israel) 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 Radiancy (Israel) Ltd. come from?
All FDA import refusal data for Radiancy (Israel) 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.