510(k) K100221
K100221 is an FDA 510(k) premarket notification submitted by Art Optical Contact Lens, Inc. for the device "INTELLIWAVE3". The FDA issued a decision of Substantially Equivalent on September 14, 2010. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Art Optical Contact Lens, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2010
- Date Received
- January 26, 2010
- 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