Spectragenics, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Spectragenics, Inc. makes
Spectragenics, Inc. manufactures laser-based hair removal systems, including the Spectra Hair Removal Laser, Tria Hair Removal Laser System, Spectra Pulsed Diode Laser (Model DR-1), and the Spectragenics ATS-1. These devices are designed for non-invasive hair reduction through targeted laser energy.
The company’s portfolio consists of Class II medical devices, all of which are subject to FDA 510(k) clearance requirements. These devices are listed under the FDA’s regulatory framework and are intended for commercial distribution in the United States.
Catalogue
Spectra Hair Removal Laser Ref K053527
Regimes: 510(k) Registry: 510(k)Tria Hair Removal Laser System Ref K090820
Regimes: 510(k) Registry: 510(k)Spectra Hair Removal Laser Ref K052848
Regimes: 510(k) Registry: 510(k)Spectragenics Ats-1 Ref K060567
Regimes: 510(k) Registry: 510(k)Spectra Pulsed Diode Laser, Model Dr-1 Ref K032846
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spectragenics, Inc. have in the registry?
The registry currently lists 5 devices for Spectragenics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spectragenics, Inc.'s devices?
Among its 5 most recently registered devices, Spectragenics, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Spectragenics, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Spectragenics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spectragenics, Inc. in the registry?
The most recently registered devices listed for Spectragenics, Inc. include SPECTRA HAIR REMOVAL LASER, TRIA HAIR REMOVAL LASER SYSTEM, SPECTRAGENICS ATS-1 and SPECTRA PULSED DIODE LASER, MODEL DR-1.