Sharplan Lasers, Inc.
United StatesFDA applicant, unverified
- Devices
- 78
What Sharplan Lasers, Inc. makes
Sharplan Lasers, Inc. manufactures CO₂ surgical lasers, including sealed-off and vaporization models, as well as Nd:YAG lasers designed for ENT and neck surgery. Their portfolio also includes remote control units, endoscopic and surgical video cameras, and synthetic contact tips for general use. Specialized accessories like lateral Nd:YAG fibers and CO₂ laser endpieces are part of their offerings.
The company’s devices are regulated under FDA Class II, Class III, and Unclassified (U) classifications, with most products cleared via the 510(k) pathway. Their products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Search and filter all 78 devicesShowing 1-50 of 78
Frequently asked questions
How many devices does Sharplan Lasers, Inc. have in the registry?
The registry currently lists 78 devices for Sharplan Lasers, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sharplan Lasers, Inc.'s devices?
Among its 50 most recently registered devices, Sharplan Lasers, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Sharplan Lasers, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Sharplan Lasers, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sharplan Lasers, Inc. in the registry?
The most recently registered devices listed for Sharplan Lasers, Inc. include SHARPLAN MODEL 1050 SEALED-OFF CO2 SURGICAL LASER, SHARPLAN MODEL 1080S CO2 SURGICAL LASER, SHARPLAN MODEL 750 REMOTE CONTROL UNIT (RCU) and SHARPLAN ND:YAG LASERS FOR ENT AND NECK SURGERY.