VivAer Stylus
FDA 510(k) clearance K200300 · decided 2020-04-13
Clearance details
- K-number
- K200300
- Device name
- VivAer Stylus
- Applicant
- Aerin Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-02-06
- Decision date
- 2020-04-13
- Days to decision
- 67 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), ste recall (Z-0808-2025) | Aerin Medical, Inc. | 2025-01-06 |