Hoya Photonics, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Hoya Photonics, Inc. makes
Hoya Photonics, Inc. manufactures Q-switched Nd:YAG laser systems for medical and dental applications, including standalone units and systems with adaptors for specific procedures. Their portfolio includes devices like the REVLITE and MEDLITE C1 for general laser treatments, the DELIGHT Dental ER and DIODENT II for dental procedures, and the LVI Aesthetic Laser for cosmetic applications.
All listed devices fall under FDA Class II regulation and are authorised via the 510(k) pathway. The company’s products are registered in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Delight Dental Er: Yag Laser System Ref K032797
Regimes: 510(k) Registry: 510(k)Medlite C1 Q-Switched Nd:yag Laser Ref K050696
Regimes: 510(k) Registry: 510(k)Diodent Ii Dental Laser System Ref K050274
Regimes: 510(k) Registry: 510(k)Lvi Aesthetic Laser Ref K041721
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hoya Photonics, Inc. have in the registry?
The registry currently lists 5 devices for Hoya Photonics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hoya Photonics, Inc.'s devices?
Among its 5 most recently registered devices, Hoya Photonics, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Hoya Photonics, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Hoya Photonics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hoya Photonics, Inc. in the registry?
The most recently registered devices listed for Hoya Photonics, Inc. include REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR, DELIGHT DENTAL ER: YAG LASER SYSTEM, MEDLITE C1 Q-SWITCHED ND:YAG LASER and DIODENT II DENTAL LASER SYSTEM.