Data / Medical devices / Denmark / AdvaLight APS
AdvaLight APS: FDA-registered device maker in Ballerup Hovedstaden, Denmark, 3 510(k) clearances
AdvaLight APS is registered with the FDA (registration 3010683226) in Ballerup Hovedstaden, Denmark. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated April 17, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010683226
- Address
- Industriparken 22 A, Ballerup Hovedstaden, Denmark, DK-2750
- Owner or operator
- AdvaLight APS (10046794)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- May 14, 2014
- Registered through
- 2026
- Brand names listed
- ADVAFx, ADVATx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| April 17, 2014 | K132976 | ADVATX | GEX | Substantially Equivalent | Advalight Aps | accessdata.fda.gov |
| June 13, 2012 | K120573 | MEDART 620 | GEX | Substantially Equivalent | Medart A/S | accessdata.fda.gov |
| May 15, 2000 | K000503 | MEDART 520 COOLING SYSTEM | GEX | Substantially Equivalent | Medart Corp. | accessdata.fda.gov |
Compare with other makers
Updated April 17, 2014. 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.