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510(k) K884188

NIDEK LM-870 AUTOMATIC LENSMETER by Nidek, Inc. — Product Code HLM

K884188 is an FDA 510(k) premarket notification submitted by Nidek, Inc. for the device "NIDEK LM-870 AUTOMATIC LENSMETER". The FDA issued a decision of Substantially Equivalent on November 23, 1988. The device falls under product code HLM (Instrument, Measuring, Lens, Ac-Powered), a Class I device regulated under 21 CFR 886.1425. Nidek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1988
Date Received
October 5, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Measuring, Lens, Ac-Powered
Device Class
Class I
Regulation Number
886.1425
Review Panel
OP
Submission Type

Other clearances by Nidek, Inc.

  • K050336 — OPD-STATION SOFTWARE (August 24, 2005)
  • 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)

Other clearances for product code HLM

  • K944022 — LENSCHEK (November 17, 1994)
  • K940997 — AL-3300 (September 29, 1994)
  • K936199 — AUTOMATIC LENSOMETER (September 28, 1994)
  • K930441 — MARCO STANDARD LENSMETERS 101,201 (July 6, 1993)
  • K930445 — MARCO LM-770 DIGITAL PROJECTION LENSMETER (June 21, 1993)
  • K924776 — BURTON LENSMETER - MODEL 2021 (April 5, 1993)
  • K924785 — BURTON RADIUSGAUGE - MODEL 2030 (April 5, 1993)
  • K924788 — BURTON LENSMETER (April 5, 1993)
  • K920861 — WOODLYN CLASSIC LENSMETER (July 30, 1992)
  • K862518 — BAUSCH & LOMB VERTOMETER V-5 (August 11, 1986)

FDA data resources