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510(k) K897186

LASER IMAGING WORK STATION by Innovision Medical, Inc. — Product Code HJI

K897186 is an FDA 510(k) premarket notification submitted by Innovision Medical, Inc. for the device "LASER IMAGING WORK STATION". The FDA issued a decision of Substantially Equivalent on March 12, 1990. The device falls under product code HJI (Lens, Fundus, Hruby, Diagnostic), a Class I device regulated under 21 CFR 886.1395. Innovision Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1990
Date Received
December 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Fundus, Hruby, Diagnostic
Device Class
Class I
Regulation Number
886.1395
Review Panel
OP
Submission Type

Other clearances by Innovision Medical, Inc.

  • K890133 — OCULAR CONNECTION MACHINE(TM) (April 12, 1989)

Other clearances for product code HJI

  • K923670 — BYRNE EXPULSIVE LENS (November 16, 1992)
  • K902138 — STRIPE PROJECTOR (July 5, 1990)
  • K901839 — 60 FUNDUS CAMERA CF-60UV (July 5, 1990)
  • K820223 — OMS QUARTZ INFUSION CONTACT LENS (February 5, 1982)
  • K802971 — LANDERS CONTACT LENS (February 5, 1981)
  • K802927 — SEBESTYEN IRRIGATING CONTACT LENS (February 5, 1981)
  • K760949 — CHARLES IRRIGATING FUNDUS CONTACT LENS (November 11, 1976)

FDA data resources