Continuum Electro-Optics, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Continuum Electro-Optics, Inc. makes
Continuum Electro-Optics, Inc. manufactures Q-switched and continuous-wave laser systems for medical and dental applications, including Nd:YAG, Er:YAG, and diode lasers. Their devices include the MedLite series (Q-switched Nd:YAG and Er:YAG lasers), the Delight Dental ER YAG laser system, and the Diodent dental laser system. These lasers are designed for procedures such as dermatological treatments, tattoo removal, and dental hard-tissue ablation.
The company’s portfolio consists of Class II medical devices, all of which are listed via the FDA’s 510(k) pathway. Their products are regulated under U.S. jurisdiction and are not cleared or approved as a company but individually per device authorisation.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Delight Dental Er: Yag Laser System Ref K021616
Regimes: 510(k) Registry: 510(k)Diodent Dental Laser System Ref K022351
Regimes: 510(k) Registry: 510(k)Multilite Erbium:yag Surgical Laser System Ref K933057
Regimes: 510(k) Registry: 510(k)Medlite Q-Swithced Laser Ref K022709
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Diodent Dental Laser System Ref K013216
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Continuum Electro-Optics, Inc. have in the registry?
The registry currently lists 7 devices for Continuum Electro-Optics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Continuum Electro-Optics, Inc.'s devices?
Among its 7 most recently registered devices, Continuum Electro-Optics, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Continuum Electro-Optics, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Continuum Electro-Optics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Continuum Electro-Optics, Inc. in the registry?
The most recently registered devices listed for Continuum Electro-Optics, Inc. include MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER, DELIGHT DENTAL ER: YAG LASER SYSTEM, DIODENT DENTAL LASER SYSTEM and MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM.