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510(k) K892204

NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS by Nidek, Inc. — Product Code LXS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1989
Date Received
April 3, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Device Class
Class II
Regulation Number
886.4392
Review Panel
OP
Submission Type

Other clearances by Nidek, Inc.

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  • K032085 — GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 (October 3, 2003)
  • K013694 — NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) (November 19, 2002)
  • K020876 — ECHOSCAN, MODEL US-1800 (May 3, 2002)
  • K014274 — NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 (April 17, 2002)
  • K013760 — DC-3300 LASER DIODE PHOTOCOAGULATOR (February 11, 2002)
  • K013864 — MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 (February 8, 2002)
  • K990119 — EPI-STAR SURGICAL LASER SYSTER (July 27, 2000)

Other clearances for product code LXS

  • K023045 — MICRORUPTER V (September 26, 2002)
  • K901605 — PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. (December 13, 1990)
  • K895864 — MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP (December 29, 1989)
  • K893987 — NIDEK MODEL YC-1200 (August 18, 1989)
  • K892058 — ISL QC 2000 (June 15, 1989)