Cleared Traditional

K023094 - IRIDIS OPHTHALMIC PHOTOCOAGULATOR (FDA 510(k) Clearance)

K023094 · Quantel Medical · Ophthalmic device

Dec 2002

Decision

90d

Days

Class 2

Risk

K023094 is an FDA 510(k) clearance for the IRIDIS OPHTHALMIC PHOTOCOAGULATOR. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).

Submitted by Quantel Medical (Hot Springs, US). The FDA issued a Cleared decision on December 17, 2002, 90 days after receiving the submission on September 18, 2002.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K023094 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 18, 2002
Decision Date	December 17, 2002
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF