510(k) K210609
K210609 is an FDA 510(k) premarket notification submitted by Vp Optics for the device "AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens". The FDA issued a decision of Substantially Equivalent on Apr 27, 2021. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 27, 2021
- Date Received
- Mar 1, 2021
- 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)