Data / Medical devices / United States / Acclaro Corporation
Acclaro Corporation: FDA-registered device maker in Smithfield, RI, United States, 2 510(k) clearances
Acclaro Corporation is registered with the FDA (registration 3021550489) in Smithfield, RI, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 8, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021550489
- Address
- 333 George washington hwy, Smithfield, RI, United States, 02917
- Owner or operator
- Acclaro Corporation (10084236)
- Roles
- Manufacturer
- First device listed
- January 28, 2022
- Registered through
- 2026
- Brand names listed
- Auralux, DiamondLux, UltraClear Fractional Laser System, UltraClear Infinity
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| May 8, 2024 | K233803 | UltraClear Laser System (N/A) | GEX | Substantially Equivalent | Acclaro Corporation | accessdata.fda.gov |
| December 10, 2021 | K210847 | UltraClear Fractional Laser System | GEX | Substantially Equivalent | Fa International, LP | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Laser Surgical Instrument With MicrobeamFractional Output
Updated May 8, 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.