510(k) K080632
K080632 is an FDA 510(k) premarket notification submitted by Clearlab SG Pte, Ltd. for the device "CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS". The FDA issued a decision of Substantially Equivalent on October 15, 2008. The device falls under product code MVN (Lens, Contact, (Disposable)), a Class II device regulated under 21 CFR 886.5925. Clearlab SG Pte, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2008
- Date Received
- March 5, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Contact, (Disposable)
- Device Class
- Class II
- Regulation Number
- 886.5925
- Review Panel
- OP
- Submission Type