510(k) K150630
K150630 is an FDA 510(k) premarket notification submitted by Yung Sheng Optical Co., Ltd. for the device "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear". The FDA issued a decision of Substantially Equivalent on June 15, 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
- June 15, 2015
- Date Received
- March 11, 2015
- 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