FDA Product Code LRX: Case, Contact Lens
Leading manufacturers include Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd., Shanghai Care US Medical Product Co., Ltd. and Avizor S.A..
FDA 510(k) Cleared Case, Contact Lens Devices (Product Code LRX)
About Product Code LRX - Regulatory Context
510(k) Submission Activity
82 total 510(k) submissions under product code LRX since 1984, with 82 receiving FDA clearance (average review time: 115 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under LRX have taken an average of 216 days to reach a decision - up from 111 days historically. Manufacturers should account for longer review timelines in current project planning.
LRX devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →