510(k) K180004
K180004 is an FDA 510(k) premarket notification submitted by Menicon Co, Ltd. for the device "Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens". The FDA issued a decision of Substantially Equivalent on February 22, 2018. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Menicon Co, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2018
- Date Received
- January 2, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lenses, Soft Contact, Daily Wear
- Device Class
- Class II
- Regulation Number
- 886.5925
- Review Panel
- OP
- Submission Type