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510(k) K843812

WOODLYN CLASSIC CATARACT ACUITY TEST by Woodlyn, Inc. — Product Code HLI

K843812 is an FDA 510(k) premarket notification submitted by Woodlyn, Inc. for the device "WOODLYN CLASSIC CATARACT ACUITY TEST". The FDA issued a decision of Substantially Equivalent on December 11, 1984. The device falls under product code HLI (Ophthalmoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1570. Woodlyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1984
Date Received
September 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances by Woodlyn, Inc.

  • K931303 — WOODLYN OPERATION MICROSCOPE (June 25, 1993)
  • K920861 — WOODLYN CLASSIC LENSMETER (July 30, 1992)
  • K900477 — WOODLYN CLASSIC SLIT LAMP MODEL SMM (February 21, 1990)
  • K900478 — WOODLYN FULL APERTURE TRIAL LENS SET (February 21, 1990)
  • K900476 — WOODLYN SLIT LAMP MODEL HR-1 (February 21, 1990)
  • K890992 — WOODLYN OPHTHALMIC PROJECTOR (May 17, 1989)
  • K874900 — WOODLYN CLASSIC REFRACTOR, PHOROPTOR (December 23, 1987)
  • K841761 — WOODLYN CLASSIC SLIT LAMP HSSL-CL (August 7, 1984)
  • K841764 — WOODLYN CLASSIC JAVAL OPHTHALMOMETER (August 7, 1984)
  • K841765 — WOODLYN STANDARD SLIT LAMP HSSL-ST (August 7, 1984)

Other clearances for product code HLI

  • K153080 — RTVue XR OCT Avanti with AngioVue Software (February 11, 2016)
  • K150722 — EnFocus 2300, EnFocus 4400 (December 2, 2015)
  • K142953 — OCT-Camera (March 4, 2015)
  • K141638 — PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE (September 17, 2014)
  • K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT (April 23, 2014)
  • K131939 — AMICO DH-W35 OPHTHALMOSCOPE SERIES (March 26, 2014)
  • K133892 — IVUE 500 (March 19, 2014)
  • K123316 — HEINE OMEGA 500 (February 26, 2013)
  • K121739 — IVUE WITH NORMATIVE DATABASE (January 18, 2013)
  • K120057 — ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) (May 11, 2012)

FDA data resources