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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-15/
- Published: 2021-08-29T12:00:00.000Z
- Updated: 2026-09-14T17:12:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138412

**DEVICES**

FDA has cleared a **Qiagen** 510(k) for the ipsogen JAK2 RGQ PCR Kit for detecting mutations affecting the Janus Tyrosine Kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating patients for suspected Polycythemia Vera (PV), according to the [agency](https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm551474.htm?ref=fdaweb.com).

The agency has cleared a **Bausch + Lomb** 510(k) for the Stellaris Elite Vision Enhancement System, the company’s next generation phacoemulsification cataract platform. The device features Adaptive Fluidics, which combines “precise aspiration control with predictive infusion management to create a highly responsive and controlled surgical environment for efficient cataract lens removal,” according to the company.

**DRUGS**

FDA has approved two **Gilead Sciences** supplemental NDAs for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17\. Previously, the therapies were approved to treat HCV in adults.

FDA has approved a **Supernus Pharmaceuticals** supplemental NDA for a label expansion for Trokendi XR (topiramate) to include migraine headache prevention in adults and adolescents 12 years and older. “Trokendi XR, with its novel formulation, provides full 24 hour coverage for patients with smooth pharmacokinetics compared to the immediate-release topiramate products, making it an important new treatment option for adult and adolescent patients suffering from migraine headache,” the company says.