NIDEK MODEL YC-1200— 510(k) K893987

Substantially Equivalent

Nidek, Inc.

FDA 510(k) clearance K893987 for NIDEK MODEL YC-1200, Substantially Equivalent on 1989-08-18. 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: 1989-06-05
Decision date: 1989-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Toro, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LXS

K023045 — MICRORUPTER V2002-09-26
K901605 — PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.1990-12-13
K895864 — MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP1989-12-29
K892204 — NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS1989-06-22
K892058 — ISL QC 20001989-06-15

More clearances from Nidek, Inc.

K050336 — OPD-STATION SOFTWARE2005-08-24
K042785 — MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-3002004-12-14
K031733 — NON-CONTACT TONOMETER, MODEL NT-40002003-12-04
K032085 — GREEN LASER PHOTOCOAGULATOR MODEL GYC-10002003-10-03
K013694 — NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)2002-11-19

Recalls naming K893987

K-number listed on FDA's recall record

Z-1367-2015 — YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses.Class II·Terminated·Nidek Inc·20150306

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K893987.

Data sourced from openFDA. This site is unofficial and independent of the FDA.