Mjolnir Pro. (Multi–electrode plasma)
FDA 510(k) clearance K233760 · decided 2024-02-20
Clearance details
- K-number
- K233760
- Device name
- Mjolnir Pro. (Multi–electrode plasma)
- Applicant
- Shenzhen Leaflife Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-11-24
- Decision date
- 2024-02-20
- Days to decision
- 88 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
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Shenzhen Leaflife Technology Co.
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 |
|---|---|---|
| Plaxpot Multi Plasma (K220493) | Gcs Co. Limited | 2023-10-27 |
| JETT PLASMA Medical II (K213247) | Compex, Spol, S.R.O. | 2023-03-14 |
| Plasma Pen (Plasma MD); Plasma Pen (Plasma +) (K223440) | Plasma Concepts | 2023-03-02 |
Recalls involving this device
No recalls on record reference this clearance.