FOTONA D.O.O.
⚠️ High Risk
FEI: 1000597018 • Ljubljana, Osrednjeslovenska • SLOVENIA
FEI Number
1000597018
Location
Ljubljana, Osrednjeslovenska
Country
SLOVENIAAddress
Stegne 7, , Ljubljana, Osrednjeslovenska, Slovenia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/10/2025 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 126FAILS STD | Division of Southeast Imports (DSEI) |
| 9/27/2018 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 47NON STD | Division of Southeast Imports (DSEI) |
| 8/6/2010 | 80LDQDEVICE, GENERAL MEDICAL | Seattle District Office (SEA-DO) | |
| 4/13/2010 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) | |
| 9/19/2002 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) | |
| 2/13/2002 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is FOTONA D.O.O.'s FDA import refusal history?
FOTONA D.O.O. (FEI: 1000597018) has 6 FDA import refusal record(s) in our database, spanning from 2/13/2002 to 11/10/2025.
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. FOTONA D.O.O.'s FEI number is 1000597018.
What types of violations has FOTONA D.O.O. received?
FOTONA D.O.O. has been cited for 6 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 FOTONA D.O.O. come from?
All FDA import refusal data for FOTONA D.O.O. 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.