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FSYX Goggles - Small 400-6009-001

by Balance Ophthalmics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860012858415 UDI-DI Date18 Mar 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
FSYX Goggles - Small
Generic Name
Intraocular pressure-reducing vacuum system goggles
Model / Reference
400-6009-001
Primary DI / UDI-DI
00860012858415
De Novo Number
FDA Product Code
QQJ
GMDN Term
Intraocular pressure-reducing vacuum system goggles
Device Class
Class II
Regulation Number
886.5000
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intraocular pressure-reducing vacuum system goggles

Cleared under the same submission (DEN230055)

Other devices from Balance Ophthalmics, Inc.

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No