The following data is part of a premarket notification filed by Suzhou 3n Biological Technology Co., Ltd with the FDA for 3n Contact Lenses Adjunct Cleaner.
| Device ID | K211361 |
| 510k Number | K211361 |
| Device Name: | 3N Contact Lenses Adjunct Cleaner |
| Classification | Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Applicant | Suzhou 3N Biological Technology Co., Ltd NO.218 Xinghu Street Suzhou, CN 215000 |
| Contact | Yang Bai |
| Correspondent | Yang Bai Suzhou 3N Biological Technology Co., Ltd NO.218 Xinghu Street Suzhou, CN 215000 |
| Product Code | LYL |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-03 |
| Decision Date | 2022-01-13 |