Cleared Traditional

SUPER VIEW DISPOSABLE BIOM LENS SET

K051630 · Insight Instruments, Inc. · Ophthalmic

Jun 2005

Decision

12d

Days

Class 2

Risk

About This 510(k) Submission

K051630 is an FDA 510(k) clearance for the SUPER VIEW DISPOSABLE BIOM LENS SET, a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II — Special Controls, product code HJK), submitted by Insight Instruments, Inc. (Sanford, US). The FDA issued a Cleared decision on June 29, 2005, 12 days after receiving the submission on June 17, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number	K051630 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2005
Decision Date	June 29, 2005
Days to Decision	12 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF