510(k) K180985
K180985 is an FDA 510(k) premarket notification submitted by Supervision Optimax Sdn Bhd for the device "Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses". The FDA issued a decision of Substantially Equivalent on Jun 8, 2018. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Supervision Optimax Sdn Bhd has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 8, 2018
- Date Received
- Apr 13, 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
- 510(k)