Data / Medical devices / Italy / Asa S.R.L.
Asa S.R.L.: FDA-registered device maker in ARCUGNANO Vicenza, Italy, 2 510(k) clearances
Asa S.R.L. is registered with the FDA (registration 3004724437) in ARCUGNANO Vicenza, Italy. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 9, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004724437
- Address
- Via Galileo Galilei, 23, ARCUGNANO Vicenza, Italy, 36057
- Owner or operator
- ASA S.R.L. (9054504)
- Roles
- Manufacturer
- First device listed
- November 7, 2005
- Registered through
- 2026
- Brand names listed
- HIRO TT US, Lumolaser, M-Hi D US, M-Hi US, M10, M7, M8, MLS M1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 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 |
|---|---|---|---|---|---|---|
| November 9, 2011 | K111901 | ASA 'MPHI FAMILY DIODE LASER | ILY | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
| September 14, 2005 | K051922 | ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6 | ILY | Substantially Equivalent | Cynosure, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 9, 2011. 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.