Data / Medical devices / Italy / Hyper Photonics S.R.L.
Hyper Photonics S.R.L.: FDA-registered device maker in Concorezzo Monza e Brianza, Italy, 1 510(k) clearance
Hyper Photonics S.R.L. is registered with the FDA (registration 3010281590) in Concorezzo Monza e Brianza, Italy. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 23, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010281590
- Address
- Via dei Mestieri 8/D, Concorezzo Monza e Brianza, Italy, 20863
- Owner or operator
- Hyper Photonics S.r.l. (10055320)
- Roles
- Manufacturer
- First device listed
- July 6, 2017
- Registered through
- 2026
- Brand names listed
- Hypho, Multipulse HO, O35
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 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 |
|---|---|---|---|---|---|---|
| June 23, 2017 | K163449 | HyPHo Laser System | GEX | Substantially Equivalent | Hyper Photonics Srl | accessdata.fda.gov |
Compare with other makers
Updated June 23, 2017. 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.