Data / Medical devices / United States / Opatra
Opatra: FDA-registered device maker in Las Vegas, NV, United States, 1 510(k) clearance
Opatra is registered with the FDA (registration 3017706553) in Las Vegas, NV, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 29, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017706553
- Address
- 5151 s Procyon st suite 105, Las Vegas, NV, United States, 89118
- Owner or operator
- Yrs group inc (10081673)
- Roles
- Repackager or relabeler
- First device listed
- May 5, 2021
- Registered through
- 2026
- Brand names listed
- Lamp, infrared, therapeutic heating, Light based over the counter wrinkle reduction
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 29, 2021 | K210954 | Synergy | OHS | Substantially Equivalent | Yrs Group, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Lamp, Infrared, Therapeutic Heating
Updated June 29, 2021. 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.