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510(k) K862713

ABRAHAM IRIDECTOMY LENS (YAG LASER) by Ocular Instruments, Inc. — Product Code HKS

K862713 is an FDA 510(k) premarket notification submitted by Ocular Instruments, Inc. for the device "ABRAHAM IRIDECTOMY LENS (YAG LASER)". The FDA issued a decision of Substantially Equivalent on August 21, 1986. 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
August 21, 1986
Date Received
July 16, 1986
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)
  • K923670 — BYRNE EXPULSIVE LENS (November 16, 1992)
  • K921414 — TROKEL /3 GONIO LASER 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)
  • K895846 — TWO MIRROR GONIO LENS (December 18, 1989)
  • K890977 — MCINTYRE SURGICAL GONIOLENS (May 23, 1989)
  • K862692 — KARICKHOFF DIAGNOSTIC/LASER LENS (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