510(k) K233221
K233221 is an FDA 510(k) premarket notification submitted by Metro Optics of Austin, Inc. for the device "Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)". The FDA issued a decision of Substantially Equivalent on February 6, 2024. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Metro Optics of Austin, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 2024
- Date Received
- September 28, 2023
- Clearance Type
- Special
- 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