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510(k) K140368

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

K140368 is an FDA 510(k) premarket notification submitted by Sensor Medical Technology, LLC for the device "FAMILY OF DISPOSABLE LENSES". The FDA issued a decision of Substantially Equivalent on April 29, 2014. The device falls under product code HKS (Prism, Gonioscopic), a Class I device regulated under 21 CFR 886.1660. Sensor Medical Technology, LLC has at least 2 other 510(k) clearances on record.

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)
  • 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