Home / 510(k) Clearances / K900478

510(k) K900478

WOODLYN FULL APERTURE TRIAL LENS SET by Woodlyn, Inc. — Product Code HPC

K900478 is an FDA 510(k) premarket notification submitted by Woodlyn, Inc. for the device "WOODLYN FULL APERTURE TRIAL LENS SET". The FDA issued a decision of Substantially Equivalent on February 21, 1990. The device falls under product code HPC (Set, Lens, Trial, Ophthalmic), a Class I device regulated under 21 CFR 886.1405. Woodlyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1990
Date Received
February 1, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Lens, Trial, Ophthalmic
Device Class
Class I
Regulation Number
886.1405
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)
  • 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)
  • K843812 — WOODLYN CLASSIC CATARACT ACUITY TEST (December 11, 1984)
  • K841767 — WOODLYN CLASSIC KERATOMETER (August 7, 1984)
  • K841761 — WOODLYN CLASSIC SLIT LAMP HSSL-CL (August 7, 1984)
  • K841764 — WOODLYN CLASSIC JAVAL OPHTHALMOMETER (August 7, 1984)

Other clearances for product code HPC

  • K945443 — BOBES LENS SET (July 19, 1995)
  • K951437 — OTI MODEL TLS-60 (April 11, 1995)
  • K930195 — OPHTHALMIC TRIAL LENSES (January 6, 1994)
  • K934859 — CONTACT LENSES (December 21, 1993)
  • K930446 — MARCO TRIAL SETS (July 6, 1993)
  • K924786 — BURTON TRIAL LENS SET (April 14, 1993)
  • K920571 — TRIAL LENS SET (May 7, 1992)
  • K873907 — CONFIRMATION TESTS (December 29, 1987)
  • K852056 — ACC CROSS CYLINDERS (June 5, 1985)
  • K843095 — TRIA LENS SET (October 5, 1984)

FDA data resources