Blade, Keratome, Reprocessed
Ophthalmic · 21 CFR 886.4370
Blade for keratome to make flap in cornea for LASIK refractive surgery. Same as previously cleared blade for keratomes, product codes HMY and HNO, except this is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Recent MDR events
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Event type breakdown
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Most-reported manufacturers
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Recalls
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Registered firms
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510(k) clearances
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No 510(k) clearances on file for this product code.