Galvanic Medical Instruments, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Galvanic Medical Instruments, Inc. makes
Galvanic Medical Instruments, Inc. manufactures microelectolysis units, including the GALTEL-18 and GUIBOR MICROELECTROLYSIS UNIT 18, designed for medical electrolysis procedures. These devices are intended for controlled tissue treatment using electrical current. The portfolio includes portable units for dermatological applications, such as hair removal and skin rejuvenation.
The company’s devices fall under Class I regulatory classification in the US, requiring 510(k) clearance through the FDA. These products are listed in the FDA’s 510(k) database as authorised medical devices. The manufacturer operates from the United States.
Catalogue
Galtel-18 Ref K821850
Regimes: 510(k) Registry: 510(k)Guibor Microelectrolysis Unit 18 Ref K851318
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Galvanic Medical Instruments, Inc. have in the registry?
The registry currently lists 2 devices for Galvanic Medical Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Galvanic Medical Instruments, Inc.'s devices?
Among its 2 most recently registered devices, Galvanic Medical Instruments, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Galvanic Medical Instruments, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Galvanic Medical Instruments, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Galvanic Medical Instruments, Inc. in the registry?
The most recently registered devices listed for Galvanic Medical Instruments, Inc. include GALTEL-18 and GUIBOR MICROELECTROLYSIS UNIT 18.