Starbene
AR Last updated 22 Oct 2026
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- Devices
- 2
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Bio SpA Intelligent Ref K992099
Sw Ultrasound, Models 331, 311, 333 Ref K991613
What Starbene makes
Starbene manufactures BIO SPA INTELLIGENT devices, which appear to be aesthetic or spa-grade equipment for body treatments, and SW ULTRASOUND models (331, 311, 333), which are likely therapeutic ultrasound systems for soft tissue applications.
These devices are classified as Class II under FDA regulations and are listed in the FDA 510(k) registry. The company is based in the United States.
Frequently asked questions
What types of medical devices does Starbene manufacture?
Starbene manufactures two primary types of devices: the BIO SPA INTELLIGENT, which is likely designed for aesthetic or spa treatments, and the SW ULTRASOUND models (331, 311, 333), which appear to be therapeutic ultrasound systems for soft tissue applications. These devices are intended for controlled medical or cosmetic use.
Where is Starbene based, and how does that affect its regulatory oversight?
Starbene is based in the United States, meaning its devices fall under FDA jurisdiction. Since the company’s products are classified as Class II under FDA regulations, they require premarket notification (510(k)) clearance before commercial distribution, ensuring compliance with safety and performance standards.
Are Starbene’s devices listed in any regulatory registries, and why does that matter?
Yes, Starbene’s devices are listed in the FDA 510(k) registry, which documents premarket submissions for Class II medical devices. This registry helps healthcare providers, regulators, and researchers verify that the devices have undergone the necessary clearance process to demonstrate substantial equivalence to legally marketed predicates, ensuring their safety and effectiveness.
How are Starbene’s devices classified by regulatory authorities, and what does that classification imply?
Starbene’s devices are classified as Class II by the FDA, which means they pose moderate risk and require special controls beyond general controls to ensure their safety and performance. This classification typically involves a 510(k) premarket notification process, where the company must demonstrate that their device is at least as safe and effective as a legally marketed predicate device.
Information
- Country
- AR