NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS— 510(k) K892204

Name: FDA 510(k) clearance K892204
Creator: U.S. Food and Drug Administration
Published: 1989-06-22

Substantially Equivalent

Nidek, Inc.

FDA 510(k) clearance K892204 for NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS, Substantially Equivalent on 1989-06-22. Applicant: Nidek, Inc.. Device class: 2.

Clearance details

Applicant: Nidek, Inc.
Product code: Code LXS
Device class: Class 2
Regulation: 21 CFR 886.4392
Advisory panel: Ophthalmic
Date received: 1989-04-03
Decision date: 1989-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Toro, CA, US

Download summary PDF View on FDA.gov ↗

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