510(k) K003170
K003170 is an FDA 510(k) premarket notification submitted by Essilor Intl. for the device "RYTHMIC AND RYTHMIC UV". The FDA issued a decision of Substantially Equivalent on December 15, 2000. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Essilor Intl. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 2000
- Date Received
- October 10, 2000
- 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