510(k) K142766
K142766 is an FDA 510(k) premarket notification submitted by INTEROJO, Inc. for the device "I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear". The FDA issued a decision of Substantially Equivalent on March 12, 2015. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. INTEROJO, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2015
- Date Received
- September 25, 2014
- 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