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LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )

Surgease Innovations Limited · Class II · Cleared Nov 30, 2023

K-numberK232262
Device nameLumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )
ApplicantSurgease Innovations Limited
Product codeFAN
Device classClass II
Decision dateNov 30, 2023
DecisionSubstantially Equivalent
Regulation876.1500
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View the full FDA submission: accessdata.fda.gov

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