Submission Details
| 510(k) Number | K211361 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
3N Contact Lenses Adjunct Cleaner
Jan 2022
Decision
255d
Days
Class 2
Risk
About This 510(k) Submission
K211361 is an FDA 510(k) clearance for the 3N Contact Lenses Adjunct Cleaner, 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 review panel. Regulated under 21 CFR 886.5928.
Device Classification
| Product Code | LYL — Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |
Manufacturer
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