Cleared Traditional

NIDEK MODEL YC-1200

K893987 · Nidek, Inc. · Ophthalmic

Aug 1989

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K893987 is an FDA 510(k) clearance for the NIDEK MODEL YC-1200, a Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla (Class II — Special Controls, product code LXS), submitted by Nidek, Inc. (El Toro, US). The FDA issued a Cleared decision on August 18, 1989, 74 days after receiving the submission on June 5, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4392.

Submission Details

510(k) Number	K893987 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 05, 1989
Decision Date	August 18, 1989
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—

Device Classification

Product Code	LXS — Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.4392