PlazMagik
FDA 510(k) K230837 · Agnes Medical Co., Ltd.
510(k) numberK230837
Submission
- Device name
- PlazMagik
- Applicant
- Agnes Medical Co., Ltd.
Seongnam-Si, KR - Received
- March 27, 2023
- Decision date
- February 29, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
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).
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| K223805 | AgnesGEI · Traditional | 05/04/2023SE |
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| K192728 | AgnesGEI · Special | 10/24/2019SE |
Questions and answers
When was PlazMagik cleared by the FDA?
PlazMagik (K230837) received a 510(k) decision of Substantially Equivalent on February 29, 2024, 339 days after the submission was received.
What is the product code of K230837?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.