Cleared Traditional

NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS

K892204 · Nidek, Inc. · Ophthalmic

Jun 1989

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K892204 is an FDA 510(k) clearance for the NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS, 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 June 22, 1989, 80 days after receiving the submission on April 3, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4392.

Submission Details

510(k) Number	K892204 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 1989
Decision Date	June 22, 1989
Days to Decision	80 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