Cleared Traditional

K030054 - DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
(FDA 510(k) Clearance)

K030054 · Fci Ophthalmics, Inc. · Ophthalmic

Feb 2003

Decision

51d

Days

Class 2

Risk

K030054 is an FDA 510(k) clearance for the DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES. This device is classified as a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II — Special Controls, product code HJK).

Submitted by Fci Ophthalmics, Inc. (Centercille, US). The FDA issued a Cleared decision on February 26, 2003, 51 days after receiving the submission on January 6, 2003.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number	K030054 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 06, 2003
Decision Date	February 26, 2003
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement