3nethra neo HD FA— 510(k) K243600
Substantially EquivalentForus Health Pvt.Ltd
FDA 510(k) clearance K243600 for 3nethra neo HD FA, Substantially Equivalent on 2025-08-14. Applicant: Forus Health Pvt.Ltd. Device class: 2.
Clearance details
- Device name as filed
- 3nethra neo HD FA; 3nethra neo HD
- Applicant
- Forus Health Pvt.Ltd
- Product code
- Code HKI
- Device class
- Class 2
- Regulation
- 21 CFR 886.1120
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bengaluru, IN
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