Data / Medical devices / China / Shanghai Wonderful Opto-Electrics Tech. Co., Ltd
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd: FDA-registered device maker in Shanghai, China, 7 510(k) clearances
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd is registered with the FDA (registration 3004505220) in Shanghai, China. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated February 28, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004505220
- Address
- 2F, Building 11, Lane 1175 Tongpu Road, Shanghai, China, 200333
- Owner or operator
- SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD (10044427)
- Roles
- Manufacturer
- First device listed
- August 14, 2014
- Registered through
- 2026
- Brand names listed
- 1060nm diode lipolysis laser, Diode Laser System, Matrix, Picasso, Sparkling, cheveux, medley
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Heat Source For Bleaching Teeth | EEG | 1 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Laser For Disruption Of Adipocyte Cells For Aesthetic Use | PKT | 2 | Manufacturer | accessdata.fda.gov |
| Laser, Dental, Soft Tissue | NVK | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 28, 2024 | K232885 | Dawn Diode Laser System | NVK | Substantially Equivalent | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | accessdata.fda.gov |
| September 23, 2022 | K222265 | Diosculpt | PKT | Substantially Equivalent | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | accessdata.fda.gov |
| August 25, 2019 | K183122 | 810nm Diode Laser System | GEX | Substantially Equivalent | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | accessdata.fda.gov |
| March 17, 2017 | K163655 | Sparkling | GEX | Substantially Equivalent | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | accessdata.fda.gov |
| September 9, 2016 | K161356 | Matrix LS-40 CO2 Laser System | GEX | Substantially Equivalent | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | accessdata.fda.gov |
| April 11, 2013 | K123777 | MULTILASER SYSTEM | GEX | Substantially Equivalent | Ultralight Laser Technologies, LLC | accessdata.fda.gov |
| March 13, 2009 | K083142 | PICASSO LASER SYSTEM | GEX | Substantially Equivalent | Amd Lasers, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Laser For Disruption Of Adipocyte Cells For Aesthetic Use
- All makers of Heat Source For Bleaching Teeth
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Laser, Dental, Soft Tissue
Updated February 28, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.