Optical Elements, Inc.
✅ Low Risk
FEI: 1000307643 • Miami, FL • UNITED STATES
FEI Number
1000307643
Location
Miami, FL
Country
UNITED STATESAddress
7681 SW 88th Street, Suite 2240, , Miami, FL, United States
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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.
Refusal History
Frequently Asked Questions
What is Optical Elements, Inc.'s FDA import refusal history?
Optical Elements, Inc. (FEI: 1000307643) has 1 FDA import refusal record(s) in our database, spanning from 6/6/2008 to 6/6/2008.
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. Optical Elements, Inc.'s FEI number is 1000307643.
What types of violations has Optical Elements, Inc. received?
Optical Elements, Inc. 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 Optical Elements, Inc. come from?
All FDA import refusal data for Optical Elements, Inc. 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.