Certificate

Device Classification Name: Lenses, Soft Contact, Daily Wear

510(K) Number: K123431

Device Name: DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D

Applicant: DREAMCON CO., LTD, 27001 La Paz Road Suite 312, Mission Viejo,CA92691

Applicant Contact: Albert Rego

Correspondent: DREAMCON CO., LTD, 27001 La Paz Road Suite 312, Mission Viejo,CA92691

Correspondent Contact: Albert Rego

Regulation Number: 886.5925

Classification Product Code: LPL

Date Received: 11/07/2012

Decision Date: 06/17/2013

Decision: Substantially Equivalent (SESE)

Regulation Medical Specialty: Ophthalmic

510k Review Panel: Ophthalmic

Statement: Statement

Type: Traditional

Reviewed By Third Party: No

Combination Product: No

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