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510(k) K935302

OSHER SURGICAL GONIO/POSTERIOR POLE LENS by Ocular Instruments, Inc. — Product Code HKS

K935302 is an FDA 510(k) premarket notification submitted by Ocular Instruments, Inc. for the device "OSHER SURGICAL GONIO/POSTERIOR POLE LENS". The FDA issued a decision of Substantially Equivalent on April 1, 1994. 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
April 1, 1994
Date Received
November 2, 1993
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)
  • 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)
  • K910828 — LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS (August 21, 1991)

Other clearances for product code HKS

  • K140368 — FAMILY OF DISPOSABLE LENSES (April 29, 2014)
  • K895846 — TWO MIRROR GONIO LENS (December 18, 1989)
  • K890977 — MCINTYRE SURGICAL GONIOLENS (May 23, 1989)
  • K862713 — ABRAHAM IRIDECTOMY LENS (YAG LASER) (August 21, 1986)
  • 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