The following data is part of a premarket notification filed by Dreamcon Co., Ltd with the FDA for Dream Color I (polymacon) Soft (hydrophilic) Contact Lens, Dream Color Ii (polymacon) Soft (hydrophilic) Contact Lens, D.
| Device ID | K123431 |
| 510k Number | K123431 |
| Device Name: | DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | DREAMCON CO., LTD 27001 LA PAZ ROAD SUITE 312 Mission Viejo, CA 92691 |
| Contact | Albert Rego |
| Correspondent | Albert Rego DREAMCON CO., LTD 27001 LA PAZ ROAD SUITE 312 Mission Viejo, CA 92691 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-07 |
| Decision Date | 2013-06-17 |
| Summary: | summary |