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510(k) K243027

Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) by Hangzhou Sightnovo Medical Technology Co., Ltd. — Product Code QLY

K243027 is an FDA 510(k) premarket notification submitted by Hangzhou Sightnovo Medical Technology Co., Ltd. for the device "Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)". The FDA issued a decision of Substantially Equivalent on April 8, 2025. 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
April 8, 2025
Date Received
September 27, 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)
  • 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