Laser Med Care
⚠️ Moderate Risk
FEI: 1000648465 • Ottawa, ON • CANADA
FEI Number
1000648465
Location
Ottawa, ON
Country
CANADAAddress
2430 Bank Street, , Ottawa, ON, Canada
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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2003 | 79MDWINSTRUMENT, MANUAL, SURGICAL, GENERAL USE | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 11/20/2003 | 86HJMTRANSILLUMINATOR, AC-POWERED | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 11/20/2003 | 86MYCOPHTHALMOSCOPE, LASER, SCANNING | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 11/20/2003 | 79MDWINSTRUMENT, MANUAL, SURGICAL, GENERAL USE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/20/2003 | 79MDWINSTRUMENT, MANUAL, SURGICAL, GENERAL USE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laser Med Care's FDA import refusal history?
Laser Med Care (FEI: 1000648465) has 5 FDA import refusal record(s) in our database, spanning from 11/20/2003 to 11/20/2003.
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. Laser Med Care's FEI number is 1000648465.
What types of violations has Laser Med Care received?
Laser Med Care has been cited for 2 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 Laser Med Care come from?
All FDA import refusal data for Laser Med Care 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.