Plasma Pen (Plasma MD); Plasma Pen (Plasma +)
FDA 510(k) clearance K223440 · decided 2023-03-02
Clearance details
- K-number
- K223440
- Device name
- Plasma Pen (Plasma MD); Plasma Pen (Plasma +)
- Applicant
- Plasma Concepts
- Decision
- Substantially Equivalent
- Date received
- 2022-11-14
- Decision date
- 2023-03-02
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- QVJ
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Woburn, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Plasma Concepts
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Mjolnir Pro. (Multi–electrode plasma) (K233760) | Shenzhen Leaflife Technology Co., Ltd. | 2024-02-20 |
| Plaxpot Multi Plasma (K220493) | Gcs Co. Limited | 2023-10-27 |
| JETT PLASMA Medical II (K213247) | Compex, Spol, S.R.O. | 2023-03-14 |
Recalls involving this device
No recalls on record reference this clearance.