Data / Medical devices / Brazil / Solotica Industria E Comercio Ltda
Solotica Industria E Comercio Ltda: FDA-registered device maker in Sao Paulo, Brazil, 1 510(k) clearance
Solotica Industria E Comercio Ltda is registered with the FDA (registration 3005994941) in Sao Paulo, Brazil. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 10, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005994941
- Address
- Rua Domingos Fasolari 110, Sao Paulo, Brazil, 02513010
- Owner or operator
- Solotica Industria E Comercio Ltda (10052935)
- Roles
- Manufacturer
- First device listed
- October 19, 2016
- Registered through
- 2026
- Brand names listed
- Hidrocor, Hidrocharme, and Natural Colors ,Hidrocor Rio Ipanema, Hidrocor Rio Buzios, Hidrocor Rio Copacabana, Hidrocor Rio Parati
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact (Other Material) - Daily | HQD | 2 | Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 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 |
|---|---|---|---|---|---|---|
| August 10, 2016 | K160472 | Hidrocor, Hidrocharme, and Natural Colors | LPL | Substantially Equivalent | Solotica | accessdata.fda.gov |
Compare with other makers
Updated August 10, 2016. 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.