Cleared Traditional

AL-3300

K940997 · Hoya Corp. USA · Ophthalmic

Sep 1994

Decision

209d

Days

Class 1

Risk

About This 510(k) Submission

K940997 is an FDA 510(k) clearance for the AL-3300, a Instrument, Measuring, Lens, Ac-powered (Class I — General Controls, product code HLM), submitted by Hoya Corp. USA (Lake Success, US). The FDA issued a Cleared decision on September 29, 1994, 209 days after receiving the submission on March 4, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1425.

Submission Details

510(k) Number	K940997 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 1994
Decision Date	September 29, 1994
Days to Decision	209 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement