510(k) K243322
- Device
- Altaviz Intravitreal Syringe
- Applicant
- Altaviz, LLC
- 510(k) number
- K243322
- Product code
- QLY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-09
- Date received
- 2024-10-23
- Regulation
- 880.5860
- Classification name
- Ophthalmic Syringe
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- James Lescoulie
- Address
- 13766 Alton Pkwy., Suite 143 Irvine CA US 92618 92618
FDA Registration Numbers#
- 3005405146
- 1064858
- 9615588
- 3012552122
- 3012478173
- 3026478941
Source Documents#
Other 510(k) Records For Product Code QLY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251849 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. | 2025-11-21 |
| K243027 | Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) | Hangzhou Sightnovo Medical Technology Co., Ltd. | 2025-04-08 |
| K243936 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. | 2025-04-03 |
| K243149 | Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) | Congruence Medical Solutions, LLC | 2024-12-20 |
| K230372 | VitreJect Syringe | Ocuject, LLC | 2023-09-08 |
| K200242 | StaClear Syringe | Tribofilm Research, Inc. | 2020-07-27 |