Cleared Abbreviated

OPHTHALMOSCOPE F-10

K072259 · Nidek Co., Ltd. · Ophthalmic
May 2008
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K072259 is an FDA 510(k) clearance for the OPHTHALMOSCOPE F-10, a Ophthalmoscope, Laser, Scanning (Class II — Special Controls, product code MYC), submitted by Nidek Co., Ltd. (Marietta, US). The FDA issued a Cleared decision on May 6, 2008, 266 days after receiving the submission on August 14, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K072259 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2007
Decision Date May 06, 2008
Days to Decision 266 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MYC — Ophthalmoscope, Laser, Scanning
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1570