The following data is part of a premarket notification filed by Unicon Optical Co., Ltd. with the FDA for Unicon (etafilcon A) Soft (hydrophilic) Contact Lens With Uv Blocker For Daily Wear.
| Device ID | K141917 |
| 510k Number | K141917 |
| Device Name: | UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | UNICON OPTICAL CO., LTD. NO. 45, MINGSHENG RD., DANSHUI DISTRICT New Taipei, TW 251 |
| Contact | Michael Lee |
| Correspondent | Michael Lee UNICON OPTICAL CO., LTD. NO. 45, MINGSHENG RD., DANSHUI DISTRICT New Taipei, TW 251 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-15 |
| Decision Date | 2014-10-17 |
| Summary: | summary |