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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Classification Name: LASER, NEODYMIUM:YAG, OPHTHALMIC FOR POSTERIOR CAPSULOTOMY AND CUTTING PUPILLA
Product Code: LXS
Device Class: 2
Regulation Number: 886.4392
Medical Specialty: Ophthalmic
Registered Establishment Name: NIDEK, INC.
Registered Establishment Number: 2936921
Owner/Operator: NIDEK CO., LTD.
Owner/Operator Number: 8030392
Establishment Operations: Manufacturer
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