Cleared Special

COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal

K191933 · Johnson & Johnson Surgical Vision, Inc. · Ophthalmic

Aug 2019

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K191933 is an FDA 510(k) clearance for the COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Johnson & Johnson Surgical Vision, Inc. (Santa Ana, US). The FDA issued a Cleared decision on August 16, 2019, 28 days after receiving the submission on July 19, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number	K191933 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2019
Decision Date	August 16, 2019
Days to Decision	28 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF