Cleared Traditional

AMER. MEDICAL OPTICS DIGITAL KERATO-

K842504 · American Medical Optics · Ophthalmic
Oct 1984
Decision
97d
Days
Class 3
Risk

About This 510(k) Submission

K842504 is an FDA 510(k) clearance for the AMER. MEDICAL OPTICS DIGITAL KERATO-, a Intraocular Lens (Class III — Premarket Approval, product code HQL), submitted by American Medical Optics (Walker, US). The FDA issued a Cleared decision on October 1, 1984, 97 days after receiving the submission on June 26, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3600.

Submission Details

510(k) Number K842504 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1984
Decision Date October 01, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HQL — Intraocular Lens
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 886.3600