510(k) K253795
K253795 is an FDA 510(k) premarket notification submitted by Menicon Co, Ltd. for the device "MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution". The FDA issued a decision of Substantially Equivalent on Aug 13, 2026. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Menicon Co, Ltd. has 18 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 13, 2026
- Date Received
- Nov 28, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Accessories, Soft Lens Products
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type
- 510(k)