Cleared Traditional

DC-3300 LASER DIODE PHOTOCOAGULATOR

K013760 · Nidek, Inc. · Ophthalmic
Feb 2002
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K013760 is an FDA 510(k) clearance for the DC-3300 LASER DIODE PHOTOCOAGULATOR, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Nidek, Inc. (Lake Forest, US). The FDA issued a Cleared decision on February 11, 2002, 90 days after receiving the submission on November 13, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K013760 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2001
Decision Date February 11, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQF — Laser, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4390