The following data is part of a premarket notification filed by Smart Performer Corp. Ltd. with the FDA for Smart Performer 55 (ocufilcon D) Soft (hydrophilic) Contact Lens.
| Device ID | K152657 |
| 510k Number | K152657 |
| Device Name: | SMART PERFORMER 55 (Ocufilcon D) 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 | 2015-09-16 |
| Decision Date | 2016-05-17 |
| Summary: | summary |