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510(k) K050336

OPD-STATION SOFTWARE by Nidek, Inc. — Product Code NCF

K050336 is an FDA 510(k) premarket notification submitted by Nidek, Inc. for the device "OPD-STATION SOFTWARE". The FDA issued a decision of Substantially Equivalent on August 24, 2005. The device falls under product code NCF (Aberrometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760. Nidek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2005
Date Received
February 10, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aberrometer, Ophthalmic
Device Class
Class I
Regulation Number
886.1760
Review Panel
OP
Submission Type

Other clearances by Nidek, Inc.

  • K042785 — MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 (December 14, 2004)
  • K031733 — NON-CONTACT TONOMETER, MODEL NT-4000 (December 4, 2003)
  • 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)
  • K990900 — MICROKERATOME, MODEL MK-2000 (September 24, 1999)

Other clearances for product code NCF

  • K062930 — LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (November 8, 2006)
  • K023249 — ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (October 18, 2002)
  • K000637 — CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) (May 19, 2000)

FDA data resources