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U.S. Department of Health and Human Services

Product Classification

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Device apparatus, cutting, radiofrequency, electrosurgical, ac-powered
Regulation Description Radiofrequency electrosurgical cautery apparatus.
Definition Used to perform anterior capsulotomy during cataract surgery.
Physical State RF power console and handpiece. The handpiece has the cutting element that delivers energy for capsulotomy.
Technical Method A corneal incision is made into the anterior chamber of the eye. A cutting element is inserted through the incision and centered on the lens capsule. Energy is directed to the cutting element, creating the capsulotomy. The cutting element is removed from the anterior chamber.
Target Area Cornea of the eye
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodePUL
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Diagnostic and Surgical Devices Branch (DSDB)
Submission Type 510(k)
Regulation Number 886.4100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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