K200300 is an FDA 510(k) clearance for the VivAer Stylus. This device is classified as a Electrosurgical, Cutting & Coagulation & Accessories (Class II - Special Controls, product code GEI).
Submitted by Aerin Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 13, 2020, 67 days after receiving the submission on February 6, 2020.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 878.4400. Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K200300 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2020 |
| Decision Date | April 13, 2020 |
| Days to Decision | 67 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | GEI - Electrosurgical, Cutting & Coagulation & Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |