The following data is part of a premarket notification filed by Shenzhen Dashicheng Optical Technology Co., Ltd. with the FDA for Barbie (polymacon) Daily Wear Soft (hydrophilic) Contact Lens.
| Device ID | K220143 |
| 510k Number | K220143 |
| Device Name: | BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Shenzhen Dashicheng Optical Technology Co., Ltd. 101, 201 And 301, Unit 3, Building 1 Wanjiening Industrial Park, No. 1450, Guanguang Road Shenzhen, CN 518110 |
| Contact | Jiayi Li |
| Correspondent | Grace Liu Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square Shenzhen, CN 518000 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-18 |
| Decision Date | 2022-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975326567787 | K220143 | 000 |
| 06975326567770 | K220143 | 000 |
| 06975326567763 | K220143 | 000 |
| 06975326561259 | K220143 | 000 |
| 06975326561051 | K220143 | 000 |
| 06975326560979 | K220143 | 000 |
| 06975326561501 | K220143 | 000 |
| 06975326564304 | K220143 | 000 |
| 06975326564298 | K220143 | 000 |