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510(k) K121738

MYVISIONTRACK(TM) by Vital Art and Science Incorporated — Product Code HOQ

K121738 is an FDA 510(k) premarket notification submitted by Vital Art and Science Incorporated for the device "MYVISIONTRACK(TM)". The FDA issued a decision of Substantially Equivalent on February 22, 2013. The device falls under product code HOQ (Grid, Amsler), a Class I device regulated under 21 CFR 886.1330. Vital Art and Science Incorporated has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2013
Date Received
June 13, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Grid, Amsler
Device Class
Class I
Regulation Number
886.1330
Review Panel
OP
Submission Type

Other clearances by Vital Art and Science Incorporated

  • K143211 — myVision Track Model 005 (March 20, 2015)

Other clearances for product code HOQ

  • K180895 — Alleye (June 27, 2018)
  • K143211 — myVision Track Model 005 (March 20, 2015)
  • K014044 — MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) (March 4, 2002)
  • K874252 — KREDA DISC (January 27, 1988)
  • K863429 — MODIFIED DEVICE FOR SELF EXAMINATION OF EYES (January 20, 1987)
  • K843227 — MACULAR FUNCTION ANALYZER (July 22, 1985)
  • K843702 — APPARATUS & METHODS SELF-EXAM OF EYE (January 3, 1985)

FDA data resources