Myopia Master— 510(k) K202989
Substantially EquivalentOculus Optikgeräte GmbH
FDA 510(k) clearance K202989 for Myopia Master, Substantially Equivalent on 2021-07-14. 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
view allRecalls naming K202989
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202989.
Data sourced from openFDA. This site is unofficial and independent of the FDA.