Cleared Traditional

KEELER MULTILASE 3000

K942180 · Keeler Instruments, Inc. · Ophthalmic
Nov 1994
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K942180 is an FDA 510(k) clearance for the KEELER MULTILASE 3000, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on November 22, 1994, 202 days after receiving the submission on May 4, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K942180 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1994
Decision Date November 22, 1994
Days to Decision 202 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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