Syneron Medical Ltd.
⚠️ Moderate Risk
FEI: 3003772750 • Illit • ISRAEL
FEI Number
3003772750
Location
Illit
Country
ISRAELAddress
Sultam Industrial Park, Tavor Building, Pob 550 Industrial Zone, Yokneam, Illit, , 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).
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/19/2016 | 79OHVFOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/6/2013 | 79NUVMASSAGER, VACCUUM, LIGHT INDUCED HEATING | 84RX DEVICE | Los Angeles District Office (LOS-DO) |
| 4/23/2013 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | New York District Office (NYK-DO) | |
| 11/2/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 8/12/2008 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/12/2008 | 79NUVMASSAGER, VACCUUM, LIGHT INDUCED HEATING | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/12/2008 | 79NUVMASSAGER, VACCUUM, LIGHT INDUCED HEATING | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/14/2005 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Syneron Medical Ltd.'s FDA import refusal history?
Syneron Medical Ltd. (FEI: 3003772750) has 8 FDA import refusal record(s) in our database, spanning from 5/14/2005 to 5/19/2016.
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. Syneron Medical Ltd.'s FEI number is 3003772750.
What types of violations has Syneron Medical Ltd. received?
Syneron Medical 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 Syneron Medical Ltd. come from?
All FDA import refusal data for Syneron Medical 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.