AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA— 510(k) K253039
Substantially EquivalentTopcon Corporation
FDA 510(k) clearance K253039 for AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA, Substantially Equivalent on 2025-11-07. Applicant: Topcon Corporation. Device class: 2.
Clearance details
- Applicant
- Topcon Corporation
- Product code
- Code HKX
- Device class
- Class 2
- Regulation
- 21 CFR 886.1930
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
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