Cleared Traditional

MICROLASE BY LASER TRABECULOPLASTY

K895213 · Keeler Instruments, Inc. · Ophthalmic
Oct 1989
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K895213 is an FDA 510(k) clearance for the MICROLASE BY LASER TRABECULOPLASTY, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on October 31, 1989, 74 days after receiving the submission on August 18, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K895213 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1989
Decision Date October 31, 1989
Days to Decision 74 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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