510(k) K143190
K143190 is an FDA 510(k) premarket notification submitted by Yung Sheng Optical Co., Ltd. for the device "Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens". The FDA issued a decision of Substantially Equivalent on January 16, 2015. The device falls under product code MVN (Lens, Contact, (Disposable)), a Class II device regulated under 21 CFR 886.5925. Yung Sheng Optical Co., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 2015
- Date Received
- November 5, 2014
- 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