Advalight
Danish developer and manufacturer of dermatology lasers, including ADVATx and ADVAFx platforms.
Company overview
Advalight develops and manufactures medical and aesthetic laser technology in Denmark. Its ADVATx platform combines 589 nm and 1319 nm wavelengths, while the newer ADVAFx platform uses CO2 laser technology for resurfacing applications.
Founded in 2006 from technical research at the Technical University of Denmark, the company has separate FDA records for ADVATx configurations. Availability of newer PRO features and ADVAFx varies by market; existing ADVATx decisions do not establish U.S. clearance for every current platform or feature.
CEO Ole Stoklund leads the company with co-founders Morten Thorhauge and Jesper Mortensen in technology and engineering roles. Commercial operations combine practitioner education, service and international distributor channels, with headquarters in Ballerup and U.S. operations in California.
Leadership
5 peopleProducts & regulatory status How does MedTechIndex get this information?
Summary
ADVATx has two documented 510(k) decisions, K132976 and K250189. The manufacturer also markets ADVAFx, but those ADVATx decisions should not be used as blanket authorization for the separate CO₂ platform. [1][6][8][9][10]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [12][13]
Regulatory snapshot How to read this snapshot
U.S. FDA- 2
- 510(k) clearances
- 0
- De Novo grants
- 0
- PMA approvals
- 0
- Recall events
Latest recorded source review: 2026-10-20.
Commercial portfolio snapshot
Documented commercial product families.
Commercial development
Current commercial platform with market-specific availability; newer features need separate authorization mapping. [1][6]
Activity & Milestones
1 eventsUpdated ADVATx FDA decision
FDA issued a substantially equivalent decision for AdvaTx. [5]
16 Cited Sources
Accessed 10/29/2026
16 Cited Sources
Accessed 10/29/2026