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510(k) K180895

Alleye by Oculocare Medical AG — Product Code HOQ

K180895 is an FDA 510(k) premarket notification submitted by Oculocare Medical AG for the device "Alleye". The FDA issued a decision of Substantially Equivalent on June 27, 2018. The device falls under product code HOQ (Grid, Amsler), a Class I device regulated under 21 CFR 886.1330.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2018
Date Received
April 5, 2018
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 for product code HOQ

  • K143211 — myVision Track Model 005 (March 20, 2015)
  • K121738 — MYVISIONTRACK(TM) (February 22, 2013)
  • 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