Syneron Candela Corporation
United StatesFDA 510(k) applicant, unverified
- Devices
- 7
What Syneron Candela Corporation makes
Syneron Candela Corporation manufactures laser-based medical devices, including the PicoWay Laser System for non-ablative skin resurfacing and the Profound System for deeper tissue treatment. These systems are designed for cosmetic and dermatological procedures, targeting skin rejuvenation, pigmentation correction, and hair removal.
The company’s portfolio consists of Class II devices, all of which are subject to 510(k) clearance through the FDA. The devices are listed under the US regulatory framework, with no additional international registries specified.
Catalogue
PicoWay Laser System Ref K162454
CE MDD 510(k) 510(k)Vbeam Prima Laser System Ref K180593
510(k) 510(k)PicoWay Laser System Ref K153527
510(k) 510(k)Syneron CO2RE System Ref K181523
510(k) 510(k)PicoWay Laser System Ref K170597
510(k) 510(k)Profound System Ref K161043
510(k) 510(k)PicoWay Laser System Ref K160607
CE MDD 510(k) 510(k)
Frequently asked questions
How many devices does Syneron Candela Corporation have in the registry?
The registry currently lists 7 devices for Syneron Candela Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Syneron Candela Corporation's devices?
Among its 7 most recently registered devices, Syneron Candela Corporation has devices listed in FDA 510(k) (7 devices).
What risk classes do Syneron Candela Corporation's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Syneron Candela Corporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Syneron Candela Corporation in the registry?
The most recently registered devices listed for Syneron Candela Corporation include PicoWay Laser System, Vbeam Prima Laser System, Syneron CO2RE System and Profound System.