K211361 is an FDA 510(k) clearance for the 3N Contact Lenses Adjunct Cleaner. This device is classified as a Accessories, Solution, Ultrasonic Cleaners For Lenses (Class II - Special Controls, product code LYL).
Submitted by Suzhou 3N Biological Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on January 13, 2022, 255 days after receiving the submission on May 3, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K211361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2021 |
| Decision Date | January 13, 2022 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LYL - Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5928 |