Cleared Traditional

MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)

K101774 · Alcon Manufacturing, Ltd. · Ophthalmic

Oct 2011

Decision

476d

Days

Class 1

Risk

About This 510(k) Submission

K101774 is an FDA 510(k) clearance for the MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4), a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Alcon Manufacturing, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on October 13, 2011, 476 days after receiving the submission on June 24, 2010. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number	K101774 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 24, 2010
Decision Date	October 13, 2011
Days to Decision	476 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF