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510(k) K820223

OMS QUARTZ INFUSION CONTACT LENS by Optical Micro Systems, Inc. — Product Code HJI

K820223 is an FDA 510(k) premarket notification submitted by Optical Micro Systems, Inc. for the device "OMS QUARTZ INFUSION CONTACT LENS". The FDA issued a decision of Substantially Equivalent on February 5, 1982. The device falls under product code HJI (Lens, Fundus, Hruby, Diagnostic), a Class I device regulated under 21 CFR 886.1395. Optical Micro Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1982
Date Received
January 27, 1982
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 Optical Micro Systems, Inc.

  • K950218 — OMS SLIMLINE PHACO HANDPIECE (July 17, 1995)
  • K946054 — DIPLOMAX (July 11, 1995)
  • K935223 — OPHTHALMIC SURGICAL SYSTEM (March 14, 1994)
  • K935226 — I/V POLE (February 16, 1994)
  • K935003 — ELECTRIC I/V POLE OR EIVP2 (January 25, 1994)
  • K870068 — ASPIRATION REVERSAL CONTROL (ARC) MODULE (February 12, 1987)
  • K844373 — O.M.S. ULTRA-PHACO (December 19, 1985)
  • K844448 — OMS/GONVERS RETINAL PERFORATOR (August 21, 1985)
  • K844895 — OMS SILICONE OIL INJECTOR (June 24, 1985)
  • K844467 — OMS CRYO (February 22, 1985)

Other clearances for product code HJI

  • K923670 — BYRNE EXPULSIVE LENS (November 16, 1992)
  • K901839 — 60 FUNDUS CAMERA CF-60UV (July 5, 1990)
  • K902138 — STRIPE PROJECTOR (July 5, 1990)
  • K897186 — LASER IMAGING WORK STATION (March 12, 1990)
  • 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