510(k) K241398
K241398 is an FDA 510(k) premarket notification submitted by Tianjin Mastervision Technology Co., Ltd. for the device "SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses". The FDA issued a decision of Substantially Equivalent on October 22, 2024. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2024
- Date Received
- May 16, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Contact (Other Material) - Daily
- Device Class
- Class II
- Regulation Number
- 886.5916
- Review Panel
- OP
- Submission Type