Strata Skin Sciences, Inc.
⚠️ Moderate Risk
FEI: 3002942014 • Carlsbad, CA • UNITED STATES
FEI Number
3002942014
Location
Carlsbad, CA
Country
UNITED STATESAddress
2375 Camino Vida Roble Ste B, , Carlsbad, 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
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 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).
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 Strata Skin Sciences, Inc.'s FDA import refusal history?
Strata Skin Sciences, Inc. (FEI: 3002942014) has 2 FDA import refusal record(s) in our database, spanning from 3/10/2003 to 3/10/2003.
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. Strata Skin Sciences, Inc.'s FEI number is 3002942014.
What types of violations has Strata Skin Sciences, Inc. received?
Strata Skin Sciences, Inc. has been cited for 3 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 Strata Skin Sciences, Inc. come from?
All FDA import refusal data for Strata Skin Sciences, 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.