Home / 510(k) Clearances / K863200

510(k) K863200

COMPUTON(R) by Optical Radiation Corp. — Product Code HKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1986
Date Received
August 19, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Ac-Powered
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

Other clearances by Optical Radiation Corp.

  • K920795 — 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX (July 13, 1992)
  • K853668 — ORC ORACLE (October 15, 1985)

Other clearances for product code HKX

  • K253039 — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA (November 7, 2025)
  • K223739 — VS Tabletop Tonometer (November 8, 2023)
  • K190382 — Intraocular Pressure Tonometer EASYTON (December 6, 2019)
  • K181260 — MiiS Horus Scope DPT 100 (June 21, 2019)
  • K181143 — Keeler TonoCare Tonometer (February 8, 2019)
  • K180820 — Tono Vue Non-Contact Tonometer (December 14, 2018)
  • K162067 — VX130 Ophthalmic Diagnostic Device (April 24, 2017)
  • K143086 — VX120 Ophthalmic Diagnostic Device (June 1, 2015)
  • K113066 — CORVIS ST (November 8, 2012)
  • K111710 — FULL AUTO TONOMETER MODEL TX-20 (September 20, 2011)