Cleared Traditional

BOLDREY PERIPHERAL RETINAL LENS

K882574 · Ocular Instruments, Inc. · Ophthalmic
Jul 1988
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K882574 is an FDA 510(k) clearance for the BOLDREY PERIPHERAL RETINAL LENS, a Lens, Surgical, Laser, Accesssory, Ophthalmic Laser (Class II — Special Controls, product code LQJ), submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on July 29, 1988, 37 days after receiving the submission on June 22, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K882574 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 1988
Decision Date July 29, 1988
Days to Decision 37 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code LQJ — Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4390

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