Cleared Special

HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+

K170520 · Alcon Research, Ltd. · Ophthalmic

Mar 2017

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K170520 is an FDA 510(k) clearance for the HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+, a Vitrectomy, Instrument Cutter (Class II — Special Controls, product code MLZ), submitted by Alcon Research, Ltd. (Lake Forest, US). The FDA issued a Cleared decision on March 22, 2017, 28 days after receiving the submission on February 22, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number	K170520 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 22, 2017
Decision Date	March 22, 2017
Days to Decision	28 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF