510(k) K103561
K103561 is an FDA 510(k) premarket notification submitted by Menicon Co, Ltd. for the device "MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS". The FDA issued a decision of Substantially Equivalent on Feb 3, 2011. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Menicon Co, Ltd. has 18 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 3, 2011
- Date Received
- Dec 6, 2010
- 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
- 510(k)