510(k) K151586
K151586 is an FDA 510(k) premarket notification submitted by Yung Sheng Optical Co., Ltd. for the device "Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens". The FDA issued a decision of Substantially Equivalent on August 10, 2015. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), 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
- August 10, 2015
- Date Received
- June 11, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lenses, Soft Contact, Daily Wear
- Device Class
- Class II
- Regulation Number
- 886.5925
- Review Panel
- OP
- Submission Type