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Dongguan Boyuan Intelligent Technology Co.,Ltd · Model KCA441-200S · UDI-DI 26977638360616

510(k) clearances

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2022-09-01	OMM Imports, Inc. dba Zero Gravity	The firm distributed the laser products without affixing the warning, aperture, certification, and identification labels. In addition, the firm failed to provide safety information

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.