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510(k) K140368

FAMILY OF DISPOSABLE LENSES by Sensor Medical Technology, LLC — Product Code HKS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2014
Date Received
February 14, 2014
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 Sensor Medical Technology, LLC

  • K152308 — Sensor Medical Single Use Tonometer Prism (October 13, 2015)
  • K142715 — Sensor Medical Family of Vitrectomy Lenses and Products (December 16, 2014)

Other clearances for product code HKS

  • 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)
  • K862713 — ABRAHAM IRIDECTOMY LENS (YAG LASER) (August 21, 1986)
  • K862512 — RITCH TRABECULOPLASTY LASER LENS (July 11, 1986)
  • K862024 — SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM (July 11, 1986)
  • K861027 — KETA HAND-HELD TONOMETER (May 6, 1986)
  • K830169 — DORC ADJUSTABLE IMAGE CONTACTS (February 7, 1983)