The following data is part of a premarket notification filed by Neo Vision Co., Ltd. with the FDA for Neo Cosmo (polymacon) Soft (hydrophilic) Contact Lens.
| Device ID | K142275 |
| 510k Number | K142275 |
| Device Name: | Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | NEO VISION CO., LTD. 1029 YEONGDOEK-DONG, GIHENUNG-GU YONGIN-SI, 17th Floor, 4-Tower Gyeonggi-do, KR |
| Contact | Kyung Hwa Kim |
| Correspondent | Albert Rego ALBERT REGO, PH.D. 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 | 2014-08-15 |
| Decision Date | 2014-10-07 |
| Summary: | summary |