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510(k) K944022

LENSCHEK by Leica, Inc. — Product Code HLM

K944022 is an FDA 510(k) premarket notification submitted by Leica, Inc. for the device "LENSCHEK". The FDA issued a decision of Substantially Equivalent on November 17, 1994. The device falls under product code HLM (Instrument, Measuring, Lens, Ac-Powered), a Class I device regulated under 21 CFR 886.1425. Leica, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1994
Date Received
August 17, 1994
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 Leica, Inc.

  • K951054 — XCEL SLIT LAMP (March 22, 1995)
  • K922770 — UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 (August 18, 1992)

Other clearances for product code HLM

  • 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)
  • K862518 — BAUSCH & LOMB VERTOMETER V-5 (August 11, 1986)

FDA data resources