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). This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.5860. 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..
| 510(k) Number | K243027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |