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510(k) K243149

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) by Congruence Medical Solutions, LLC — Product Code QLY

K243149 is an FDA 510(k) premarket notification submitted by Congruence Medical Solutions, LLC for the device "Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)". The FDA issued a decision of Substantially Equivalent on December 20, 2024. The device falls under product code QLY (Ophthalmic Syringe), a Class II device regulated under 21 CFR 880.5860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2024
Date Received
September 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmic Syringe
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

An Ophthalmic Syringe is a piston syringe intended for intraocular injections. The device consists of a calibrated hollow barrel, a movable plunger, and may include a needle. The device should be used by health care professionals to perform injections into the eye.

Other clearances for product code QLY

  • K251849 — StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250L (November 21, 2025)
  • K243322 — Altaviz Intravitreal Syringe (May 9, 2025)
  • K243027 — Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC I (April 8, 2025)
  • K243936 — StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250L (April 3, 2025)
  • K230372 — VitreJect Syringe (September 8, 2023)
  • K200242 — StaClear Syringe (July 27, 2020)

FDA data resources