Tixel i (TXLI0001)— 510(k) K240512
Substantially EquivalentNovoxel , Ltd.
FDA 510(k) clearance K240512 for Tixel i (TXLI0001), Substantially Equivalent on 2024-11-04. Applicant: Novoxel , Ltd.. Device class: 2.
Clearance details
- Applicant
- Novoxel , Ltd.
- Product code
- Code ORZ
- Device class
- Class 2
- Regulation
- 21 CFR 886.5200
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Netanya, IL
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