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510(k) K844716

MAGNIFYING SPECTACLES W/PLASTIC LENSES by Gazelle Corp. — Product Code HOI

K844716 is an FDA 510(k) premarket notification submitted by Gazelle Corp. for the device "MAGNIFYING SPECTACLES W/PLASTIC LENSES". The FDA issued a decision of Substantially Equivalent on January 3, 1985. The device falls under product code HOI (Spectacle, Magnifying), a Class I device regulated under 21 CFR 886.5840. Gazelle Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1985
Date Received
December 4, 1984
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 by Gazelle Corp.

  • K820375 — PLASTIC OR GLASS MAGNIFIER (June 14, 1982)

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)
  • K854854 — SYSTEMS OF SIGHT LOW VISION EYEWARE (February 4, 1986)
  • 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