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FDA 510(k)

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

K-Number: K243027 · 2025-04-08

ApplicantHangzhou Sightnovo Medical Technology Co., Ltd.
Decision Date2025-04-08
Product CodeQLY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Sightnovo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-08 under 510(k) number K243027. The device is classified under product code QLY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)?

Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) is a medical device that received FDA 510(k) clearance on 2025-04-08. The listed applicant is Hangzhou Sightnovo Medical Technology Co., Ltd.. The 510(k) number is K243027.

When did Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) receive FDA 510(k) clearance?

Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) received FDA 510(k) clearance on 2025-04-08, under 510(k) number K243027.

Who is the listed applicant for Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)?

The FDA 510(k) record lists Hangzhou Sightnovo Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)?

The FDA product code for Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) is QLY.

Related Devices (Code: QLY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251849StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc.K243322Altaviz Intravitreal SyringeAltaviz, LLCK243936StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc.K243149Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)Congruence Medical Solutions, LLCK230372VitreJect SyringeOcuject, LLCK200242StaClear SyringeTribofilm Research, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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