Can I read FDA Approval for Optica XT Laser Device on EtoBox?
FDA Approval for Optica XT Laser Device by 蒋科学 is a document available to read on EtoBox.
What is FDA Approval for Optica XT Laser Device about?
The document is a 510(k) premarket notification letter from the FDA regarding the Optica XT Thulium Fiber Laser and Accessories, confirming its substantial equivalence to a predicate device. The device is classified as Class II and is intended for various surgical applications, including urology and gastroenterology. The letter outlines compliance requirements and provides information on the device
- Author
- 蒋科学
- Language
- EN