510(k) K123431
K123431 is an FDA 510(k) premarket notification submitted by Dreamcon Co., Ltd. for the device "DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D". The FDA issued a decision of Substantially Equivalent on Jun 17, 2013. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 17, 2013
- Date Received
- Nov 7, 2012
- 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
- 510(k)