Data / Medical devices / Italy / Lambda SPA
Lambda SPA: FDA-registered device maker in Brendola Vicenza, Italy, 2 510(k) clearances
Lambda SPA is registered with the FDA (registration 3007689729) in Brendola Vicenza, Italy. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 28, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007689729
- FEI number
- 3008697515
- Address
- via dell impresa 1, Brendola Vicenza, Italy, 36040
- Owner or operator
- LAMBDA SPA (10029199)
- Roles
- Manufacturer
- First device listed
- September 22, 2009
- Registered through
- 2026
- Brand names listed
- DOCTOR SMILE WISER, DOCTOR SMILE WISER REVOLUTION, Doctor Smile A-810 B-980 Lasers, Helios Laser HL5, Helios Laser Inc., LAMBDA SpA
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 |
|---|---|---|---|---|---|---|
| September 28, 2010 | K102036 | DOCTOR SURGERY DIODE LASERS FAMILY | GEX | Substantially Equivalent | Lambda S.P.A. | accessdata.fda.gov |
| September 8, 2009 | K091562 | DOCTOR SMILE A-810 AND B-980 LASERS | GEX | Substantially Equivalent | Lambda Scientific Spa | accessdata.fda.gov |
Compare with other makers
Updated September 28, 2010. 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.