Pentacam® Cornea OCT— 510(k) K251848
Substantially EquivalentOculus Optikgeräte GmbH
FDA 510(k) clearance K251848 for Pentacam® Cornea OCT, Substantially Equivalent on 2026-03-13. Applicant: Oculus Optikgeräte GmbH. Device class: 2.
Clearance details
- Applicant
- Oculus Optikgeräte GmbH
- Product code
- Code MXK
- Device class
- Class 2
- Regulation
- 21 CFR 886.1850
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wetzlar, DE
Recent devices under product code MXK
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