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U.S. Department of Health and Human Services

Product Classification

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Device laser,system,phacolysis
Regulation Description Phacofragmentation system.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeMXO
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Intraocular and Corneal Implants Devices Branch (ICIB)
Submission Type 510(k)
Regulation Number 886.4670
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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