The following data is part of a premarket notification filed by Smart Performer Corp. Ltd. with the FDA for Smart Performer (polymacon) Soft (hydrophilic) Contact Lens.
| Device ID | K151847 |
| 510k Number | K151847 |
| Device Name: | SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | SMART PERFORMER CORP. LTD. NO.13-1, WUQUAN 1ST RD., XINZHUANG DIST. New Taipei City, TW 242 |
| Contact | Jeffersion Shen |
| Correspondent | Jeffersion Shen SMART PERFORMER CORP. LTD. NO.13-1, WUQUAN 1ST RD., XINZHUANG DIST. New Taipei City, TW 242 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-07 |
| Decision Date | 2016-03-04 |
| Summary: | summary |