483
IPG Medical CorporationFDA 483 - IPG Medical Corporation - November 04, 2025
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IPG Medical Corporation in Marlborough, MA, was inspected by the FDA from October 29 to November 4, 2025. The inspection revealed a significant safety concern regarding their Class 4 Thuvera Laser System, which lacked a required removable key to prevent unauthorized operation. This indicates a potential risk related to laser product safety controls.
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