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510(k) K912268

LANDERS NOTCHED VITRECTOMY LENS RING by Ocular Instruments, Inc. — Product Code HNH

K912268 is an FDA 510(k) premarket notification submitted by Ocular Instruments, Inc. for the device "LANDERS NOTCHED VITRECTOMY LENS RING". The FDA issued a decision of Substantially Equivalent on August 7, 1991. The device falls under product code HNH (Ring, Ophthalmic (Flieringa)), a Class I device regulated under 21 CFR 886.4350. Ocular Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1991
Date Received
May 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ring, Ophthalmic (Flieringa)
Device Class
Class I
Regulation Number
886.4350
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 HNH

  • K912269 — LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING (August 7, 1991)
  • K912151 — LANDERS THREE STRUT VITRECTOMY LENS RING (July 25, 1991)
  • K902496 — LANDERS VITRECTOMY LENS RING W/INFUSION (July 24, 1990)
  • K863775 — RK VACUUM FIXATION RING SYSTEM (October 20, 1986)
  • K850991 — LANDERS VITRECTOMY LENS RING SYSTEMS (March 29, 1985)
  • K832912 — GELENDER VACUUM FIXATION RING SYS (January 10, 1984)

FDA data resources