Cleared Traditional

K843345 - AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON
(FDA 510(k) Clearance)

K843345 · Mira, Inc. · Ophthalmic device
Nov 1984
Decision
71d
Days
—
Risk

K843345 is an FDA 510(k) clearance for the AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON..

Submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on November 6, 1984, 71 days after receiving the submission on August 27, 1984.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K843345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1984
Decision Date November 06, 1984
Days to Decision 71 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code —
Device Class —