Cleared Traditional

MICROLASE 8 0 0 (OPHTHALMIC LASER)

K890086 · Keeler Instruments, Inc. · Ophthalmic
Mar 1989
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K890086 is an FDA 510(k) clearance for the MICROLASE 8 0 0 (OPHTHALMIC LASER), a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on March 15, 1989, 64 days after receiving the submission on January 10, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K890086 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 1989
Decision Date March 15, 1989
Days to Decision 64 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