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510(k) K861064

LM-850 AUTOMATIC LENSMETER by Nidek, Inc. — Product Code HLM

K861064 is an FDA 510(k) premarket notification submitted by Nidek, Inc. for the device "LM-850 AUTOMATIC LENSMETER". The FDA issued a decision of Substantially Equivalent on April 15, 1986. 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
April 15, 1986
Date Received
March 20, 1986
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)
  • K924788 — BURTON LENSMETER (April 5, 1993)
  • K924785 — BURTON RADIUSGAUGE - MODEL 2030 (April 5, 1993)
  • K920861 — WOODLYN CLASSIC LENSMETER (July 30, 1992)
  • K884188 — NIDEK LM-870 AUTOMATIC LENSMETER (November 23, 1988)

FDA data resources