Sunny Optoelectronic Tech Co.Ltd
⚠️ Moderate Risk
FEI: 3009769082 • Shanghai, Shanghai • CHINA
FEI Number
3009769082
Location
Shanghai, Shanghai
Country
CHINAAddress
F 2, No 1661 Jia Luo Highway; Jiading, Shanghai, Shanghai, 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
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.
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).
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.
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.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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 |
|---|---|---|---|
| 7/31/2014 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Los Angeles District Office (LOS-DO) | |
| 7/31/2013 | 89ONHPOWERED LASER NON-THEMAL INSTRUMENT WITH NON-HEATING EFFECT FOR ADJUNCTIVE USE IN PATH THERAPY | Cincinnati District Office (CIN-DO) | |
| 6/27/2013 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Sunny Optoelectronic Tech Co.Ltd's FDA import refusal history?
Sunny Optoelectronic Tech Co.Ltd (FEI: 3009769082) has 3 FDA import refusal record(s) in our database, spanning from 6/27/2013 to 7/31/2014.
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. Sunny Optoelectronic Tech Co.Ltd's FEI number is 3009769082.
What types of violations has Sunny Optoelectronic Tech Co.Ltd received?
Sunny Optoelectronic Tech Co.Ltd has been cited for 7 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 Sunny Optoelectronic Tech Co.Ltd come from?
All FDA import refusal data for Sunny Optoelectronic Tech 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.