FDA 510(k) 实质等同认定·2026-09-02· 原文未提供具体时分510(k) 实质等同认定:1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)(K261589)来源:FDA 510(k) 实质等同认定 · accessdata.fda.gov