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510(k) K014170

STAURENGHI WIDE FIELD SCANNING LASER LENS by Ocular Instruments, Inc. — Product Code HJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2002
Date Received
December 20, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class
Class II
Regulation Number
886.1385
Review Panel
OP
Submission Type

Other clearances by Ocular Instruments, Inc.

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  • 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)
  • K910828 — LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS (August 21, 1991)

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  • K033950 — DORC VITRECTOMY LENSES, MODEL 1284 SERIES (February 20, 2004)
  • K030054 — DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES (February 26, 2003)
  • K023221 — CONTACT LASER & DIAGNOSTIC LENSES (October 11, 2002)