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510(k) K861027

KETA HAND-HELD TONOMETER by Keta Corp. — Product Code HKS

K861027 is an FDA 510(k) premarket notification submitted by Keta Corp. for the device "KETA HAND-HELD TONOMETER". The FDA issued a decision of Substantially Equivalent on May 6, 1986. The device falls under product code HKS (Prism, Gonioscopic), a Class I device regulated under 21 CFR 886.1660. Keta Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1986
Date Received
March 18, 1986
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 Keta Corp.

  • K861028 — SUPERLITE PENLIGHT (April 4, 1986)
  • K844570 — QUANTUM 412 (December 5, 1984)

Other clearances for product code HKS

  • K140368 — FAMILY OF DISPOSABLE LENSES (April 29, 2014)
  • 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)
  • K830169 — DORC ADJUSTABLE IMAGE CONTACTS (February 7, 1983)

FDA data resources