Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)— 510(k) K243027

Name: FDA 510(k) clearance K243027
Creator: U.S. Food and Drug Administration
Published: 2025-04-08

Substantially Equivalent

Hangzhou Sightnovo Medical Technology Co., Ltd.

FDA 510(k) clearance K243027 for Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27), Substantially Equivalent on 2025-04-08. Applicant: Hangzhou Sightnovo Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hangzhou Sightnovo Medical Technology Co., Ltd.
Product code: Code QLY
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2024-09-27
Decision date: 2025-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou City, CN

Download summary PDF View on FDA.gov ↗

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