Submission Details
| 510(k) Number | K210300 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 03, 2021 |
| Decision Date | April 01, 2021 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
Apr 2021
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K210300 is an FDA 510(k) clearance for the VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System, a Accessories, Solution, Ultrasonic Cleaners For Lenses (Class II — Special Controls, product code LYL), submitted by Vuesonic, LLC (Miami Beach, US). The FDA issued a Cleared decision on April 1, 2021, 57 days after receiving the submission on February 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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