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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-93/
- Published: 2019-05-27T12:00:00.000Z
- Updated: 2026-09-15T01:28:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5132215

**DEVICES**

FDA has cleared a **Cynosure** 510(k) for the SculpSure, a hyperthermic laser treatment for lipolysis of the flanks. The device works by disrupting subcutaneous fat cells. The hands-free device features a flexible applicator system to treat multiple anatomical areas of the body, according to the company. SculpSure, which uses a 1060 nm laser, can treat an anatomical area in about 25 minutes.

FDA has cleared a **Nitiloop** 510(k) for its NovaCross, which is intended to be used in conjunction with a guidewire to access discrete regions of the coronary or peripheral vasculature. The device functions both as a competent supporting microcatheter and as a premium low-profile microcatheter on its own, according to the company. Its support use comes from the operator-controlled Nitinol scaffold and an extendable segment, both located at its distal end.

**Visage Imaging Inc.** has received FDA 510(k) clearance for the use the Visage Ease Pro for mobile diagnostic interpretation of all imaging modalities except mammography.

**HUMAN DRUGS**

FDA has approved a **Janssen Pharmaceuticals** NDA for Invega Trinza (paliperidone palmitate), a three-month long-acting atypical antipsychotic indicated to treat schizophrenia. Before starting Invega Trinza, patients must be adequately treated with Invega Sustenna (one-month paliperidone palmitate) for at least four months. The submission received a priority review.