Sheaumann Lasers
Country not established
- Devices
- 2
What Sheaumann Lasers makes
Sheaumann Lasers manufactures medical laser systems, including the PL-1064 and PL-980 models, designed for dermatological and cosmetic procedures. These devices are intended for controlled tissue ablation, pigment removal, and vascular lesion treatment using specific wavelength outputs. Their products are engineered for clinical use in dermatology offices and laser treatment centers.
The company’s portfolio is classified under FDA’s Class II medical devices and is subject to 510(k) clearance requirements. These devices are listed in the FDA’s 510(k) database, adhering to U.S. regulatory standards for laser-based medical instruments. Sheaumann Lasers operates from the United States, where its products are authorized for commercial distribution.
Catalogue
Sheaumann Pl-1064 Ref K111359
Regimes: 510(k) Registry: 510(k)Sheaumann Pl-980 Ref K111360
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sheaumann Lasers have in the registry?
The registry currently lists 2 devices for Sheaumann Lasers. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sheaumann Lasers's devices?
Among its 2 most recently registered devices, Sheaumann Lasers has devices listed in FDA 510(k) (2 devices).
What risk classes do Sheaumann Lasers's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sheaumann Lasers's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sheaumann Lasers in the registry?
The most recently registered devices listed for Sheaumann Lasers include SHEAUMANN PL-1064 and SHEAUMANN PL-980.