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510(k) K930445

MARCO LM-770 DIGITAL PROJECTION LENSMETER by Marco Ophthalmic, Inc. — Product Code HLM

K930445 is an FDA 510(k) premarket notification submitted by Marco Ophthalmic, Inc. for the device "MARCO LM-770 DIGITAL PROJECTION LENSMETER". The FDA issued a decision of Substantially Equivalent on June 21, 1993. The device falls under product code HLM (Instrument, Measuring, Lens, Ac-Powered), a Class I device regulated under 21 CFR 886.1425. Marco Ophthalmic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1993
Date Received
January 26, 1993
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 Marco Ophthalmic, Inc.

  • K943234 — MS-30 AUTOMATIC PERIMETER (July 27, 1994)
  • K930442 — MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS (August 9, 1993)
  • K930444 — MARCO STANDARD KERATOMETERS (August 9, 1993)
  • K930438 — MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS (August 9, 1993)
  • K930437 — MARCO STANDARD RADIUSGAUGES (August 9, 1993)
  • K930439 — MARCO SURGISCOPE OPERATION MICROSCOPES (July 22, 1993)
  • K930440 — MARCO INTERNATIONAL STAND (July 6, 1993)
  • K930446 — MARCO TRIAL SETS (July 6, 1993)
  • K930441 — MARCO STANDARD LENSMETERS 101,201 (July 6, 1993)
  • K930449 — MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR (July 6, 1993)

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)
  • K924788 — BURTON LENSMETER (April 5, 1993)
  • K924776 — BURTON LENSMETER - MODEL 2021 (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)
  • K862518 — BAUSCH & LOMB VERTOMETER V-5 (August 11, 1986)

FDA data resources