Recently Approved Devices

Restylane Lyft with Lidocaine - P040024/S099
Restylane® Lyft with Lidocaine is a clear injectable dermal filler gel. This supplement expands the indication for Restylane Lyft with Lidocaine to include being intended to help improve the appearance of aging hands with moderate to severe volume loss. Restylane® Lyft with Lidocaine consists of hyaluronic acid and lidocaine.

SYNOJOYNT™ - P170016
SYNOJOYNT™ contains a single‐use syringe prefilled with a thick substance made of sodium hyaluronate in a salt water (saline) solution for injection in the osteoarthritic knee joint. This substance is similar to hyaluronic acid found in the knee joint space.

CustomFlex™ Artificial Iris - P170039
The CustomFlex Artificial Iris is a prosthetic iris (the colored part of the eye around the pupil) made of thin, foldable medical-grade silicone. This device is custom-made and can be sized and colored for each individual patient. The CustomFlex Artificial Iris can be used to treat congenital (genetic disorder in which the iris is completely or partially absent) and traumatic aniridia.It can also be used to treat iris defects due to other reasons or conditions, such as albinism, or surgical removal due to melanoma.

Abbott RealTime IDH2 - P170005
The Abbott RealTime IDH2 is a laboratory test intended to detect the presence of nine (9) specific mutations in the isocitrate dehydrogenase-2 (IDH2) gene in blood or bone marrow from patients with relapsed or refractory (residual leukemic cells in the marrow even after intensive treatment) acute myeloid leukemia (AML). If the test result is positive for IDH2 mutation, the patient may be able to achieve remission and require fewer blood transfusions when treated with IDHIFA (enasidenib), a drug that targets the mutant IDH2 protein