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.
Summary
Oculus Optikgeräte's Pentacam® Cornea OCT is filed under MXK, anterior segment analysis devices. The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 886.1850. Ophthalmic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Oculus Optikgeräte filed from Wetzlar, Germany. Review took 270 calendar days (June 16, 2025 to March 13, 2026).
Clearance details
- Applicant
- Oculus Optikgeräte GmbH
- Product code
- Product 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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