Skip to content

FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System

by Balance Ophthalmics, Inc.

De Novo DEN230055

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN230055 Date27 Jun 2024DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
QQJ
Device Class
Class II
Regulation
21 CFR Part 886.5000
Advisory Committee
Ophthalmic
FDA Decision
DENG De Novo granted

Other devices from Balance Ophthalmics, Inc.