MRC · Class II · 21 CFR 886.5918

FDA Product Code MRC: Products, Contact Lens Care, Rigid Gas Permeable

Leading manufacturers include Ophtecs Corporation.

33
Total
33
Cleared
111d
Avg days
1998
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 113d avg (recent)

FDA 510(k) Cleared Products, Contact Lens Care, Rigid Gas Permeable Devices (Product Code MRC)

33 devices
1–24 of 33
Cleared Oct 09, 2025
cleadew GP hydra one
K251876
Ophtecs Corporation
Ophthalmic · 113d

About Product Code MRC - Regulatory Context

510(k) Submission Activity

33 total 510(k) submissions under product code MRC since 1998, with 33 receiving FDA clearance (average review time: 111 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

FDA review times for MRC submissions have been consistent, averaging 113 days recently vs 111 days historically.

MRC devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →