510(k) K173538
K173538 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc". The FDA issued a decision of Substantially Equivalent on December 4, 2017. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Alcon Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 2017
- Date Received
- November 15, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Case, Contact Lens
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type