Beijing Toplaser Technology Co., Ltd.
⚠️ Moderate Risk
FEI: 3005450614 • Beijing, Beijing • CHINA
FEI Number
3005450614
Location
Beijing, Beijing
Country
CHINAAddress
East 3rd Floor, Building M7, NO. 1 Jiuxianqiao Donglu, Beijing, Beijing, China
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
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).
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.
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
NO TAG
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 to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
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).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/19/2017 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 6/17/2014 | 79NRJULTRASOUND, SKIN PERMEATION | Los Angeles District Office (LOS-DO) | |
| 4/30/2014 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Los Angeles District Office (LOS-DO) | |
| 7/25/2012 | 79OHVFOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION | Cincinnati District Office (CIN-DO) | |
| 7/20/2012 | 79OHVFOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION | Cincinnati District Office (CIN-DO) | |
| 7/26/2011 | 79NUVMASSAGER, VACCUUM, LIGHT INDUCED HEATING | Seattle District Office (SEA-DO) | |
| 7/20/2010 | 79NAGLIGHT, SPECTRUM, BROAD | Chicago District Office (CHI-DO) | |
| 10/29/2007 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Beijing Toplaser Technology Co., Ltd.'s FDA import refusal history?
Beijing Toplaser Technology Co., Ltd. (FEI: 3005450614) has 8 FDA import refusal record(s) in our database, spanning from 10/29/2007 to 4/19/2017.
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. Beijing Toplaser Technology Co., Ltd.'s FEI number is 3005450614.
What types of violations has Beijing Toplaser Technology Co., Ltd. received?
Beijing Toplaser Technology Co., Ltd. has been cited for 9 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 Beijing Toplaser Technology Co., Ltd. come from?
All FDA import refusal data for Beijing Toplaser Technology Co., Ltd. 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.