Cleared Traditional

TOMEY DTL ELECTRODE

K961805 · Tomey Corporation USA · Ophthalmic
May 1997
Decision
364d
Days
Class 2
Risk

About This 510(k) Submission

K961805 is an FDA 510(k) clearance for the TOMEY DTL ELECTRODE, a Electrode, Corneal (Class II — Special Controls, product code HLZ), submitted by Tomey Corporation USA (Cambridge, US). The FDA issued a Cleared decision on May 9, 1997, 364 days after receiving the submission on May 10, 1996. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1220.

Submission Details

510(k) Number K961805 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 1996
Decision Date May 09, 1997
Days to Decision 364 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HLZ — Electrode, Corneal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1220