Shanghai Wonderful Opto-Electrics Tech. Co., Ltd.
Manufacturer and brand owner in Shanghai, China. 5 device types, 1 product catalogued, 6 clearances.
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Laser, Dental, Soft Tissue, Heat Source For Bleaching Teeth and 3 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2014.
Registration
| Registered name | SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004505220 |
| FEI number | 3004505220 |
| DUNS | 723541293 |
| Establishment type | Manufacturer |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 2F, Building 11, Lane 1175 |
| Postal code | 200333 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Heat Source For Bleaching Teeth | Class 1 | Diode Laser System | 2024 | 56 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | Diode Laser System | 2024 | 235 |
| Laser For Disruption Of Adipocyte Cells For Aesthetic Use | Class 2 | 1060nm diode lipolysis laser | 2022 | 7 |
| Laser, Dental, Soft Tissue | Class 2 | Diode Laser System | 2024 | 5 |
| Powered Laser Surgical Instrument | Class 2 | cheveux, Matrix, Picasso, medley, Diode Laser System, Sparkling | 2014 | 92 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Swot | GEX | 4 |
Clearances
6 clearances name Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K243037 | 2024-12-26 | GEX | Traditional | This company |
| K232885 | 2024-02-28 | NVK | Traditional | This company |
| K222265 | 2022-09-23 | PKT | Traditional | This company |
| K183122 | 2019-08-25 | GEX | Traditional | This company |
| K163655 | 2017-03-17 | GEX | Traditional | This company |
| K161356 | 2016-09-09 | GEX | Traditional | This company |
| K123777 | 2013-04-11 | GEX | Traditional | Ultralight Laser Technologies, LLC |
| K083142 | 2009-03-13 | GEX | Traditional | Amd Lasers, LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1998 |
|---|---|
| Main products | CO2 lasers, Diode lasers, Hair removal systems, Nd:YAG lasers, Multi-function laser systems |
| Certifications | CE, FDA |
| Export markets | Global |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.