Pentacam AXL— 510(k) K152311
Substantially EquivalentOculus Optikgerate GmbH
FDA 510(k) clearance K152311 for Pentacam AXL, Substantially Equivalent on 2016-01-20. 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
- Wetzla, DE
Recent devices under product code MXK
view allMore clearances from Oculus Optikgerate GmbH
view allRecalls naming K152311
K-number listed on FDA's recall record- Z-2483-2023 — Oculus Pentacam AXL , Ref 70100, CE 0123
- Z-1673-2022 — Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
- Z-0635-2018 — OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber, and lens of the eye, to evaluate corneal shape, analyze condition of the lens (opaque crystalline lens), analyze the anterior chamber angle, analyze anterior chamber depth, analyze the volume of the anterior chamber, analyze anterior or posterior cortical opacity, analyze the location of cataracts (nuclear, sub capsular and/or cortical), using cross slit imaging with densitometry, corneal thickness, axial length, and white-to-white distance. The Pentacam AXL also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152311.
Data sourced from openFDA. This site is unofficial and independent of the FDA.