FDA Import Refusal 799-7744738-3/12/1 — BLUEONE

BLUEONE — FEI 3033553330

The FDA refused shipment 799-7744738-3/12/1 from BLUEONE (South Korea) on Apr 30, 2025. The refused product falls under Devices — ABLATION SYSTEM, HIGH INTENSITY FOCUS ULTRASOUND (HIFU), SOFT TISSUE. Cited charges: 118,3280 This firm has 3 other import refusals on record.