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510(k) K895846

TWO MIRROR GONIO LENS by Ocular Instruments, Inc. — Product Code HKS

K895846 is an FDA 510(k) premarket notification submitted by Ocular Instruments, Inc. for the device "TWO MIRROR GONIO LENS". The FDA issued a decision of Substantially Equivalent on December 18, 1989. The device falls under product code HKS (Prism, Gonioscopic), a Class I device regulated under 21 CFR 886.1660. Ocular Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1989
Date Received
October 3, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prism, Gonioscopic
Device Class
Class I
Regulation Number
886.1660
Review Panel
OP
Submission Type

Other clearances by Ocular Instruments, Inc.

  • K014170 — STAURENGHI WIDE FIELD SCANNING LASER LENS (March 4, 2002)
  • K012096 — DISPOSABLE VITRECTOMY LENS (August 24, 2001)
  • K933976 — MANDELKORN SUTURE LYSIS LENS (November 8, 1994)
  • K933264 — RITCH NYLON SUTURE LASER LENS (October 31, 1994)
  • K941420 — 50 DEGREE HRI PRISM LENS (August 29, 1994)
  • K935302 — OSHER SURGICAL GONIO/POSTERIOR POLE LENS (April 1, 1994)
  • K921414 — TROKEL /3 GONIO LASER LENS (November 16, 1992)
  • K923670 — BYRNE EXPULSIVE LENS (November 16, 1992)
  • K914051 — PEDIATRIC VITRECTOMY LENS SET (December 9, 1991)
  • K914117 — LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET (November 13, 1991)

Other clearances for product code HKS

  • K140368 — FAMILY OF DISPOSABLE LENSES (April 29, 2014)
  • K935302 — OSHER SURGICAL GONIO/POSTERIOR POLE LENS (April 1, 1994)
  • K890977 — MCINTYRE SURGICAL GONIOLENS (May 23, 1989)
  • K862692 — KARICKHOFF DIAGNOSTIC/LASER LENS (August 21, 1986)
  • K862713 — ABRAHAM IRIDECTOMY LENS (YAG LASER) (August 21, 1986)
  • K862024 — SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM (July 11, 1986)
  • K862512 — RITCH TRABECULOPLASTY LASER LENS (July 11, 1986)
  • K861027 — KETA HAND-HELD TONOMETER (May 6, 1986)
  • K830169 — DORC ADJUSTABLE IMAGE CONTACTS (February 7, 1983)

FDA data resources