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510(k) K854854

SYSTEMS OF SIGHT LOW VISION EYEWARE by Int'L Eye Care, Inc. — Product Code HOI

K854854 is an FDA 510(k) premarket notification submitted by Int'L Eye Care, Inc. for the device "SYSTEMS OF SIGHT LOW VISION EYEWARE". The FDA issued a decision of Substantially Equivalent on February 4, 1986. The device falls under product code HOI (Spectacle, Magnifying), a Class I device regulated under 21 CFR 886.5840.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1986
Date Received
December 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spectacle, Magnifying
Device Class
Class I
Regulation Number
886.5840
Review Panel
OP
Submission Type

Other clearances for product code HOI

  • K943613 — NIL (September 21, 1994)
  • K930435 — SPECTACLE FRAMES (September 20, 1993)
  • K931328 — PYRAMID SUNGLASSES/PYRAMID READING GLASSES (August 10, 1993)
  • K910329 — SUNGLASSES (March 12, 1991)
  • K844716 — MAGNIFYING SPECTACLES W/PLASTIC LENSES (January 3, 1985)
  • K844038 — VISITEC MAGNIFYING SPECTACLES (November 29, 1984)
  • K842835 — BRILLETTE MODEL (November 21, 1984)
  • K820732 — LA VEL LATERAL VIEW EXTENSION LENS (May 3, 1982)
  • K813548 — UVEX MINI-SPECS (March 2, 1982)
  • K801733 — FENZL RETICLE (September 16, 1980)

FDA data resources