Active Optical Systems, Ltd.
⚠️ Moderate Risk
FEI: 3005180774 • Petach-Tikva • ISRAEL
FEI Number
3005180774
Location
Petach-Tikva
Country
ISRAELAddress
11, Shoham Street, , Petach-Tikva, , 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).
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.
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).
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 |
|---|---|---|---|
| 11/14/2014 | 79ONGPOWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/15/2014 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Los Angeles District Office (LOS-DO) | |
| 9/11/2014 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Active Optical Systems, Ltd.'s FDA import refusal history?
Active Optical Systems, Ltd. (FEI: 3005180774) has 3 FDA import refusal record(s) in our database, spanning from 9/11/2014 to 11/14/2014.
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. Active Optical Systems, Ltd.'s FEI number is 3005180774.
What types of violations has Active Optical Systems, Ltd. received?
Active Optical Systems, Ltd. has been cited for 4 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 Active Optical Systems, Ltd. come from?
All FDA import refusal data for Active Optical Systems, 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.