Device Classification Name |
Lenses, Soft Contact, Daily Wear
|
510(k) Number |
K222954 |
Device Name |
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens |
Applicant |
Innova Vision Inc. |
2F., No. 20, Prosperity Rd. 1, Hsinchu Science Park |
Hsinchu,
TW
300091
|
|
Applicant Contact |
Kari Huang |
Correspondent |
Innova Vision Inc. |
2F., No. 20, Prosperity Rd. 1, Hsinchu Science Park |
Hsinchu,
TW
300091
|
|
Correspondent Contact |
Kari Huang |
Regulation Number | 886.5925
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/27/2022 |
Decision Date | 03/13/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|