> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-43/
- Published: 2022-03-20T12:00:00.000Z
- Updated: 2026-09-14T17:37:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138965

**DEVICES**

FDA has cleared a **Hologic** 510(k) for the Cynosure body contouring product, SculpSure, to treat the back and inner and outer thighs. The SculpSure treatment is already FDA-cleared for treating abdomen and love handles (flanks). Hologic says the device uses a selective wavelength laser to precisely target fat cells under the skin.

FDA has cleared an **Etiometry** 510(k) for the Inadequate Oxygen Delivery (IDO2) Index for monitoring intensive care unit patients aged 12 years or younger. Originally cleared by the agency in 2016 for tracking the clinical risk of inadequate oxygen delivery to neonatal patients, the new clearance now allows hospitals to use the IDO2 Index for older patients.

**DRUGS**

FDA has approved a **Teva Pharmaceuticals** ANDA for the first generic copy of **Gilead**’s Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg) for treating HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk. Emtricitabine and tenofovir disoproxil fumarate used for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use, according to the agency.