Data / Medical devices / United Kingdom / Opatra Ltd
Opatra Ltd: FDA-registered device maker in London London, City of, United Kingdom, 2 510(k) clearances
Opatra Ltd is registered with the FDA (registration 3012541016) in London London, City of, United Kingdom. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 28, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012541016
- Address
- 447 high road, London London, City of, United Kingdom, n120af
- Owner or operator
- OPATRA LTD (10053739)
- Roles
- Manufacturer
- First device listed
- January 6, 2017
- Registered through
- 2026
- Brand names listed
- Lamp, infrared, therapeutic heating, Laser, comb, hairOver-the-counter powered light based laser for acne, Light based over the counter wrinkle reduction Over-the-counter powered light based laser for acne, MASSAGER, THERAPEUTIC, MANUAL, Massager, therapeutic, electric, Massager, therapeutic, to internally massage trigger points in the pelvic floor musculature, prescription use
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Laser, Comb, Hair | OAP | 2 | Manufacturer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Manual | LYG | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use | QKD | 2 | Manufacturer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 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 |
|---|---|---|---|---|---|---|
| April 28, 2023 | K230597 | Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) | OAP | Substantially Equivalent | Light Tree Ventures Europe B.V. | accessdata.fda.gov |
| December 20, 2022 | K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) | OHS | Substantially Equivalent | Light Tree Ventures Europe B.V. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Manual
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Laser, Comb, Hair
- All makers of Massager, Therapeutic, Electric
Updated April 28, 2023. 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.