510(k) K201194
K201194 is an FDA 510(k) premarket notification submitted by Acuity Polymers, Inc. for the device "Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens". The FDA issued a decision of Substantially Equivalent on September 8, 2020. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Acuity Polymers, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 2020
- Date Received
- May 4, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Contact (Other Material) - Daily
- Device Class
- Class II
- Regulation Number
- 886.5916
- Review Panel
- OP
- Submission Type