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510(k) K920861

WOODLYN CLASSIC LENSMETER by Woodlyn, Inc. — Product Code HLM

K920861 is an FDA 510(k) premarket notification submitted by Woodlyn, Inc. for the device "WOODLYN CLASSIC LENSMETER". The FDA issued a decision of Substantially Equivalent on July 30, 1992. The device falls under product code HLM (Instrument, Measuring, Lens, Ac-Powered), a Class I device regulated under 21 CFR 886.1425. Woodlyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1992
Date Received
February 25, 1992
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 Woodlyn, Inc.

  • K931303 — WOODLYN OPERATION MICROSCOPE (June 25, 1993)
  • K900477 — WOODLYN CLASSIC SLIT LAMP MODEL SMM (February 21, 1990)
  • K900476 — WOODLYN SLIT LAMP MODEL HR-1 (February 21, 1990)
  • K900478 — WOODLYN FULL APERTURE TRIAL LENS SET (February 21, 1990)
  • K890992 — WOODLYN OPHTHALMIC PROJECTOR (May 17, 1989)
  • K874900 — WOODLYN CLASSIC REFRACTOR, PHOROPTOR (December 23, 1987)
  • K843812 — WOODLYN CLASSIC CATARACT ACUITY TEST (December 11, 1984)
  • K841764 — WOODLYN CLASSIC JAVAL OPHTHALMOMETER (August 7, 1984)
  • K841761 — WOODLYN CLASSIC SLIT LAMP HSSL-CL (August 7, 1984)
  • K841767 — WOODLYN CLASSIC KERATOMETER (August 7, 1984)

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)
  • K924788 — BURTON LENSMETER (April 5, 1993)
  • K924776 — BURTON LENSMETER - MODEL 2021 (April 5, 1993)
  • K924785 — BURTON RADIUSGAUGE - MODEL 2030 (April 5, 1993)
  • K884188 — NIDEK LM-870 AUTOMATIC LENSMETER (November 23, 1988)
  • K862518 — BAUSCH & LOMB VERTOMETER V-5 (August 11, 1986)

FDA data resources