Cleared Traditional

Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)

K243027 · Hangzhou Sightnovo Medical Technology Co., Ltd. · General Hospital

Apr 2025

Decision

193d

Days

Class 2

Risk

About This 510(k) Submission

K243027 is an FDA 510(k) clearance for the Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27), a Ophthalmic Syringe (Class II — Special Controls, product code QLY), submitted by Hangzhou Sightnovo Medical Technology Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on April 8, 2025, 193 days after receiving the submission on September 27, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K243027 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2024
Decision Date	April 08, 2025
Days to Decision	193 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	QLY — Ophthalmic Syringe
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5860
Definition	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.