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510(k) K251849

StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) by Staclear, Inc. — Product Code QLY

K251849 is an FDA 510(k) premarket notification submitted by Staclear, Inc. for the device "StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)". The FDA issued a decision of Substantially Equivalent on November 21, 2025. The device falls under product code QLY (Ophthalmic Syringe), a Class II device regulated under 21 CFR 880.5860. Staclear, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2025
Date Received
June 16, 2025
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 by Staclear, Inc.

  • K243936 — StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250L (April 3, 2025)

Other clearances for product code QLY

  • 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)
  • K243149 — Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) (December 20, 2024)
  • K230372 — VitreJect Syringe (September 8, 2023)
  • K200242 — StaClear Syringe (July 27, 2020)

FDA data resources