Aculux, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Aculux, Inc. makes
Aculux, Inc. manufactures XENALIGHT models AX9125 and AX9225, which are medical-grade light sources designed for surgical and procedural illumination. The AX9125 operates on 100–120V AC power, while the AX9225 is configured for 220–240V AC applications, both intended for use in clinical settings requiring precise and adjustable lighting.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is headquartered in the United States, where its products are registered for commercial distribution.
Catalogue
Aculux, Model AX3001, AX3002 Ref K001223
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aculux, Inc. have in the registry?
The registry currently lists 2 devices for Aculux, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aculux, Inc.'s devices?
Among its 2 most recently registered devices, Aculux, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Aculux, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Aculux, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aculux, Inc. in the registry?
The most recently registered devices listed for Aculux, Inc. include ACULUX, MODEL AX3001, AX3002 and XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~).