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510(k) K782096

INSTRUMENTS, OVERREFRACTION SYSTEM by Zeiss Humphrey System — Product Code HLM

K782096 is an FDA 510(k) premarket notification submitted by Zeiss Humphrey System for the device "INSTRUMENTS, OVERREFRACTION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 26, 1979. The device falls under product code HLM (Instrument, Measuring, Lens, Ac-Powered), a Class I device regulated under 21 CFR 886.1425. Zeiss Humphrey System has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1979
Date Received
December 18, 1978
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 Zeiss Humphrey System

  • K942439 — ZEISS OPMILAS 144 SURGICAL LASERS (July 1, 1994)
  • K923211 — DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE (November 8, 1993)
  • K923348 — OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED (December 10, 1992)
  • K852639 — HUMPHREY FIELD ANALYZER MODEL 630 (September 18, 1985)
  • K852638 — HUMPHREY IMAGE ANALYZER MODEL 110 (August 12, 1985)
  • K821940 — THE HUMPHREY FIELD ANALYZER MODEL 610 (July 28, 1982)
  • K802029 — OBJECTIVE REFRACTOR (November 12, 1980)
  • K781994 — AUTOKERATOMETER, INSTRUMENT (February 12, 1979)

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