LASER LIPO LIMITED
⚠️ Moderate Risk
FEI: 3010497317 • Edenbridge, Kent • UNITED KINGDOM
FEI Number
3010497317
Location
Edenbridge, Kent
Country
UNITED KINGDOMAddress
Heath House, , Edenbridge, Kent, United Kingdom
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.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/22/2021 | 79OLIFAT REDUCING LOW LEVEL LASER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/3/2020 | 79OLIFAT REDUCING LOW LEVEL LASER | Division of Northern Border Imports (DNBI) | |
| 4/21/2020 | 79OLIFAT REDUCING LOW LEVEL LASER | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 3/31/2020 | 79OLIFAT REDUCING LOW LEVEL LASER | 47NON STD | Division of Southeast Imports (DSEI) |
| 3/25/2020 | 79OLIFAT REDUCING LOW LEVEL LASER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/24/2020 | 79OLIFAT REDUCING LOW LEVEL LASER | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/28/2020 | 79OLIFAT REDUCING LOW LEVEL LASER | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 2/25/2020 | 79OLIFAT REDUCING LOW LEVEL LASER | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 2/24/2020 | 79OLIFAT REDUCING LOW LEVEL LASER | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 5/14/2018 | 79OLIFAT REDUCING LOW LEVEL LASER | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 12/14/2017 | 79OLIFAT REDUCING LOW LEVEL LASER | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 10/6/2016 | 79OYWFOR THE REMOVAL OF FAT THROUGH LASER LIPOLYSIS | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 5/16/2016 | 79OLIFAT REDUCING LOW LEVEL LASER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/16/2015 | 79OLIFAT REDUCING LOW LEVEL LASER | Cincinnati District Office (CIN-DO) | |
| 3/30/2015 | 95RHLLASER THERAPY PRODUCT | Los Angeles District Office (LOS-DO) | |
| 5/27/2014 | 79OLIFAT REDUCING LOW LEVEL LASER | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is LASER LIPO LIMITED's FDA import refusal history?
LASER LIPO LIMITED (FEI: 3010497317) has 16 FDA import refusal record(s) in our database, spanning from 5/27/2014 to 3/22/2021.
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 LIPO LIMITED's FEI number is 3010497317.
What types of violations has LASER LIPO LIMITED received?
LASER LIPO LIMITED has been cited for 8 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 LIPO LIMITED come from?
All FDA import refusal data for LASER LIPO LIMITED 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.