The following data is part of a premarket notification filed by Bonraybio Co., Ltd. with the FDA for Lenshooke X1 Pro Semen Quality Analyzer, Lenshooke X1 Pro Se Semen Quality Analyzer.
| Device ID | K202089 |
| 510k Number | K202089 |
| Device Name: | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer |
| Classification | Semen Analysis Device |
| Applicant | Bonraybio Co., Ltd. 4F., No.118, Gongye 9th Rd. Dali Dist. Taichung, TW 41280 |
| Contact | Brown Hsu |
| Correspondent | Feng-yu Lee Dynamic Biotech, Inc Dba. IVDD Regulatory Consultant 29122 Rancho Viejo Rd., Suite 212 San Juan Capistrano, CA 92675 |
| Product Code | POV |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-28 |
| Decision Date | 2020-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14719874741157 | K202089 | 000 |
| 44719874740717 | K202089 | 000 |
| 44719874740762 | K202089 | 000 |
| 44719874741141 | K202089 | 000 |
| 44719874741158 | K202089 | 000 |
| 54719874740714 | K202089 | 000 |
| 54719874740769 | K202089 | 000 |
| 54719874741148 | K202089 | 000 |
| 54719874741155 | K202089 | 000 |
| 14719874741140 | K202089 | 000 |
| 04719874741570 | K202089 | 000 |