certificate

MANUFACTURER'S APPROVALS & CERTIFICATES

US FDA

Device Classification Name: Lenses, Soft Contact, Daily Wear

510(K) Number: K110835

Device Name: GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS

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

Applicant Contact: Albert Rego

Correspondent: GEO MEDICAL 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: 03/25/2011

Decision Date: 04/26/2012

Decision: Substantially Equivalent (SESE)

Regulation Medical Specialty: Ophthalmic

510k Review Panel: Ophthalmic

Statement: Statement

Type: Traditional

Reviewed By Third Party: No

Combination Product: No

OTHERS
  • US FDA

  • Canada HC

  • ISO 13485: 2003

  • EU CE:1370

  • Hong Kong MDACS

  • Taiwan FDA

  • Russia GostR

  • Vietnam VFA

  • Singapore HSA

  • Korea KGMP

  • China SFDA

  • Japan MHLW

US FDA

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

OTHERS
  • Canada ISO 13485

  • Canada Medical Device Licence

  • CE

  • China SFDA

  • Russia GOST R

  • ISO 9001

  • ISO 13485

  • Japan FDA

  • Thai FDA

  • US FDA

US FDA

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

OTHERS
  • Canada CMDCAS

  • CE 1370 – Lens

  • CE 1370 – Solution

  • China SFDA

  • Korea GMP

  • Hong Kong FDA

  • ISO 13485 BV2015

  • Patent EN

  • Slovakia

  • US FDA