510(k) K142284
K142284 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE". The FDA issued a decision of Substantially Equivalent on January 26, 2015. The device falls under product code LPN (Accessories, Soft Lens Products), 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
- January 26, 2015
- Date Received
- August 18, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Soft Lens Products
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type