Device Classification Name: Lenses, Soft Contact, Daily Wear
510(K) Number: K142275
Device Name: Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens
Applicant: NEO VISION CO., LTD., 1029 Yeongdoek-Dong, Gihenung-Gu, Yongin-Si, 17th Floor, 4-Tower, Gyeonggi-Do,KR
Applicant Contact: Kyung Hwa Kim
Correspondent: ALBERT REGO, PH.D., 27001 La Paz Road, Suite 312, Mission Viejo,CA92691
Correspondent Contact: Albert Rego
Regulation Number: 886.5925
Classification Product Code: LPL
Date Received: 08/15/2014
Decision Date: 10/07/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
510k Review Panel: Ophthalmic
Statement: Statement
Type: Traditional
Reviewed By Third Party: No
Combination Product: No