Systane iLux2— 510(k) K200400
Substantially EquivalentTear Film Innovations, Inc.
FDA 510(k) clearance K200400 for Systane iLux2, Substantially Equivalent on 2020-05-21. Applicant: Tear Film Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Tear Film Innovations, Inc.
- 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
- Carlsbad, CA, US
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