GEO MEDICAL CO., LTD. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
GEO MEDICAL CO., LTD. - FDA 510(k) Cleared Devices
Recent clearances: PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS
2
Total
2
Cleared
0
Denied
GEO MEDICAL CO., LTD. specializes in ophthalmic devices, with a manufacturing facility in Mission Viejo, US. The company develops soft contact lenses for vision correction and cosmetic applications.
GEO MEDICAL has received 2 FDA 510(k) clearances from 2 total submissions since 2012. The company maintains a 100% clearance rate in the ophthalmic category. The latest clearance was granted in 2026, confirming the company remains active in FDA regulatory submissions.
The company's cleared portfolio includes soft hydrophilic contact lenses in various materials and tint options. These products address both functional vision correction and cosmetic enhancement needs in the contact lens market.
Explore the complete list of device names, product codes, and clearance dates in the database to review GEO MEDICAL's regulatory history and cleared products.
510(k) submissions have been managed by Andre Vision and Device Research as regulatory consultant.
FDA 510(k) Regulatory Record - GEO MEDICAL CO., LTD.
2 devices