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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-25/
- Published: 2021-11-07T12:00:00.000Z
- Updated: 2026-09-14T17:21:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142311

**DEVICES**

FDA has cleared a **Surgical Innovation Associates** 510(k) for DuraSorb Monofilament Mesh, a line of bioabsorbable technologies for reconstructive and cosmetic surgery. “Much like an absorbable stitch, DuraSorb Monofilament Mesh is designed to integrate into the patient’s tissue – providing strong support during the critical initial phases of healing – and then slowly dissolve, leaving the patient free from foreign material within one year,” the company says. “The device brings cutting-edge polymer science and evidence-based engineering to bear on a material that has been safely used in other surgical applications for decades.”

FDA has cleared an **Iridex** 510(k) for the TruFocus LIO Premiere laser accessory, a light combination and reflection viewing system used with the Iridex retina laser systems and is worn on the physician’s head. “The product combines a laser treatment beam from an Iridex laser source with the illumination beam of a binocular indirect ophthalmoscope into a mixed optical beam used by a physician with a handheld ophthalmic examination lens to enter a patient’s pupil and to view and treat a patient’s retina,” the company says.  
  
**DRUGS**

FDA has approved **Teva**’s Cassipa (buprenorphine and naloxone) sublingual film for maintenance treatment of opioid dependence. An agency [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619864.htm?ref=fdaweb.com) says the approval provides a new 16 mg/4 mg dosage strength of buprenorphine and naloxone sublingual film. The drug was approved through the 505(b)(2) abbreviated approval pathway that relied, in part, on an FDA finding of safety and effectiveness for Suboxone sublingual film to support approval.