Polytec Pi, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Polytec Pi, Inc. makes
Polytec Pi, Inc. manufactures Q-switched ruby laser systems, including standalone Q-switched ruby lasers and combined long-pulse/Q-switched ruby laser systems. These devices are designed for medical applications requiring precise laser energy delivery, such as dermatological treatments and tattoo removal.
The company’s laser systems are classified as Class II devices under FDA regulations and are listed via 510(k) clearance. The portfolio is authorised for use in the United States.
Catalogue
Laseaway Q-Switched Ruby Laser System Ref K942343
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Polytec Pi, Inc. have in the registry?
The registry currently lists 2 devices for Polytec Pi, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Polytec Pi, Inc.'s devices?
Among its 2 most recently registered devices, Polytec Pi, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Polytec Pi, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Polytec Pi, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Polytec Pi, Inc. in the registry?
The most recently registered devices listed for Polytec Pi, Inc. include LASEAWAY Q-SWITCHED RUBY LASER SYSTEM and LASEAWAY LONG PULSE AND Q-SWITCHED RUBY LASER SYSTEM.