Sciton Inc.
⚠️ Moderate Risk
FEI: 3001415984 • Palo Alto, CA • UNITED STATES
FEI Number
3001415984
Location
Palo Alto, CA
Country
UNITED STATESAddress
925 Commercial St, , Palo Alto, CA, United States
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
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.
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 |
|---|---|---|---|
| 11/7/2012 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 118NOT LISTED | Minneapolis District Office (MIN-DO) |
| 10/28/2011 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 11/6/2009 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 126FAILS STD | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sciton Inc.'s FDA import refusal history?
Sciton Inc. (FEI: 3001415984) has 3 FDA import refusal record(s) in our database, spanning from 11/6/2009 to 11/7/2012.
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. Sciton Inc.'s FEI number is 3001415984.
What types of violations has Sciton Inc. received?
Sciton 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 Sciton Inc. come from?
All FDA import refusal data for Sciton 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.