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510(k) K241931

OcuMet Beacon (OCUB100) by Ocusciences, Inc. — Product Code MYC

K241931 is an FDA 510(k) premarket notification submitted by Ocusciences, Inc. for the device "OcuMet Beacon (OCUB100)". The FDA issued a decision of Substantially Equivalent on April 22, 2025. The device falls under product code MYC (Ophthalmoscope, Laser, Scanning), a Class II device regulated under 21 CFR 886.1570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2025
Date Received
July 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Laser, Scanning
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances for product code MYC

  • K243504 — MAIA (AHMACME001) (March 17, 2025)
  • K213705 — DRSplus (December 21, 2021)
  • K211328 — EIDON FA, EIDON, EIDON AF, EIDON UWFL (August 19, 2021)
  • K192113 — DRSplus (November 15, 2019)
  • K180526 — EIDON FA (July 16, 2018)
  • K180293 — Retia 2 (May 30, 2018)
  • K153181 — MAIA (June 8, 2016)
  • K150320 — COMPASS (June 30, 2015)
  • K142897 — P200DTx (January 16, 2015)
  • K142047 — EIDON (November 12, 2014)

FDA data resources