Pentacam AXL Wave— 510(k) K201724
Substantially EquivalentOculus Optikgerate GmbH
FDA 510(k) clearance K201724 for Pentacam AXL Wave, Substantially Equivalent on 2020-10-21. Applicant: Oculus Optikgerate GmbH. Device class: 2.
Clearance details
- Applicant
- Oculus Optikgerate 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
view allMore clearances from Oculus Optikgerate GmbH
view allRecalls naming K201724
K-number listed on FDA's recall record- Z-2482-2023 — Oculus Pentacam AXL Wave, Ref 70020, CE 0123
- Z-1672-2022 — Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201724.
Data sourced from openFDA. This site is unofficial and independent of the FDA.