510(k) K142384
K142384 is an FDA 510(k) premarket notification submitted by Qualimed Srl for the device "DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)". The FDA issued a decision of Substantially Equivalent on Dec 12, 2014. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Qualimed Srl has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 12, 2014
- Date Received
- Aug 26, 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
- 510(k)