Data / Medical devices / China / Olemy Laser Technology Ltd
Olemy Laser Technology Ltd: FDA-registered device maker in Wuxi Jiangsu, China, 1 510(k) clearance
Olemy Laser Technology Ltd is registered with the FDA (registration 3015218136) in Wuxi Jiangsu, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 30, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015218136
- Address
- Zone A, Zone B, Floor 4, D3, No. 1719-3 Huishan Avenue, Huishan Economic Development District, Wuxi Jiangsu, China, 214000
- Owner or operator
- Olemy Laser Technology LTD. (10059782)
- Roles
- Manufacturer
- First device listed
- February 21, 2019
- Registered through
- 2026
- Brand names listed
- Advanced Skin Renewing Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 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 |
|---|---|---|---|---|---|---|
| November 30, 2018 | K182498 | Advanced Skin Renewing Device | ONG | Substantially Equivalent | Jiangsu Unimed Laser Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 30, 2018. 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.