MRC

Products, Contact Lens Care, Rigid Gas Permeable

Product code
MRC
Device name
Products, Contact Lens Care, Rigid Gas Permeable
Device class
Class 2
21 CFR
21 CFR 886.5918
Medical specialty
Ophthalmic
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
33 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-10-09.

NumberDecision dateApplicantDevice nameSummary
K2518762025-10-09Ophtecs Corporationcleadew GP hydra onePDF

1 summaries are archived here for direct download.

Official FDA classification page: MRC
Classification and pathway per current FDA publications. Data from openFDA (CC0).