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510(k) K844038

VISITEC MAGNIFYING SPECTACLES by Visitec Co. — Product Code HOI

K844038 is an FDA 510(k) premarket notification submitted by Visitec Co. for the device "VISITEC MAGNIFYING SPECTACLES". The FDA issued a decision of Substantially Equivalent on November 29, 1984. The device falls under product code HOI (Spectacle, Magnifying), a Class I device regulated under 21 CFR 886.5840. Visitec Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1984
Date Received
October 16, 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 Visitec Co.

  • K953394 — VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} (October 12, 1995)
  • K945114 — VISITEC SCLERAL PLUG (February 23, 1995)
  • K945738 — VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE (February 14, 1995)
  • K945172 — VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS (January 17, 1995)
  • K942234 — VISITEC PRECISE-POINT (July 12, 1994)
  • K934269 — FIBEROPTIC ILLUMINATED INSTRUMENTS (May 17, 1994)
  • K940210 — VISITEC EYE PAD (March 7, 1994)
  • K933872 — VISI-SPEAR EYE SPONGE (December 27, 1993)
  • K923972 — OPHTHALMIC FLUID DISTRIBUTION SETS (November 4, 1992)
  • K922530 — VISITEC MICROSURGICAL SUTURE (October 20, 1992)

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)
  • K844716 — MAGNIFYING SPECTACLES W/PLASTIC LENSES (January 3, 1985)
  • 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