Plaxpot Multi Plasma
FDA 510(k) clearance K220493 · decided 2023-10-27
Clearance details
- K-number
- K220493
- Device name
- Plaxpot Multi Plasma
- Applicant
- Gcs Co. Limited
- Decision
- Substantially Equivalent
- Date received
- 2022-02-22
- Decision date
- 2023-10-27
- Days to decision
- 612 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
- Seongnam, KR
- Third-party review
- No
- Expedited review
- No
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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 |
| 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.