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510(k) K844895

OMS SILICONE OIL INJECTOR by Optical Micro Systems, Inc. — Product Code LWL

K844895 is an FDA 510(k) premarket notification submitted by Optical Micro Systems, Inc. for the device "OMS SILICONE OIL INJECTOR". The FDA issued a decision of Substantially Equivalent on June 24, 1985. The device falls under product code LWL (Fluid, Intraocular), a Class III device regulated under 21 CFR 886.4275. Optical Micro Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1985
Date Received
December 17, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluid, Intraocular
Device Class
Class III
Regulation Number
886.4275
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)
  • K844467 — OMS CRYO (February 22, 1985)
  • K844715 — VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY (January 22, 1985)

FDA data resources