ImportRefusal LogoImportRefusal

Venus Concept

✅ Low Risk

FEI: 3008747554 • Karmiel • ISRAEL

FEI

FEI Number

3008747554

📍

Location

Karmiel

🇮🇱

Country

ISRAEL
🏢

Address

62 Hahermesh Street, , Karmiel, , Israel

Low Risk

FDA Import Risk Assessment

21.7
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

3
Total Refusals
1
Unique Violations
5/1/2018
Latest Refusal
5/1/2018
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

3413×

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).

Refusal History

DateProductViolationsDivision
5/1/2018
79PBXMASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT
341REGISTERED
Division of Southeast Imports (DSEI)
5/1/2018
79PBXMASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT
341REGISTERED
Division of Southeast Imports (DSEI)
5/1/2018
79PBXMASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Venus Concept's FDA import refusal history?

Venus Concept (FEI: 3008747554) has 3 FDA import refusal record(s) in our database, spanning from 5/1/2018 to 5/1/2018.

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. Venus Concept's FEI number is 3008747554.

What types of violations has Venus Concept received?

Venus Concept has been cited for 1 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 Venus Concept come from?

All FDA import refusal data for Venus Concept 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.