The following data is part of a premarket notification filed by Vuesonic, Llc with the FDA for Vuesonic One Contact Lens Cleaning System, Vuesonic Advance 2 Contact Lens Cleaning System.
| Device ID | K210300 |
| 510k Number | K210300 |
| Device Name: | VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System |
| Classification | Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Applicant | VueSonic, LLC 1234 Washington Ave., #205 Miami Beach, FL 33139 |
| Contact | Sheri Ker |
| Correspondent | Marc C. Sanchez Contract In-House Counsel And Consultants,LLC (d/b/a FDA Att 1717 Pennsylvania Ave. NW, Suite #1025 Washington, DC 20006 |
| Product Code | LYL |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-03 |
| Decision Date | 2021-04-01 |