Density
FDA 510(k) K230663 · Jeisys Medical, Inc.
510(k) numberK230663
Submission
- Device name
- Density
- Applicant
- Jeisys Medical, Inc.
Seoul, KR - Received
- March 10, 2023
- Decision date
- August 14, 2023
- 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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| K231216 | PotenzaGEI · Traditional | 12/10/2024SE |
| K231287 | PotenzaGEI · Traditional | 11/05/2024SE |
| K223685 | SmoothCool HR SystemGEX · Special | 01/04/2023SE |
| K213484 | SmoothCool HR SystemGEX · Special | 04/20/2022SE |
| K201685 | PotenzaGEI · Traditional | 01/19/2021SE |
| K192545 | PotenzaGEI · Traditional | 02/20/2020SE |
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Questions and answers
When was Density cleared by the FDA?
Density (K230663) received a 510(k) decision of Substantially Equivalent on August 14, 2023, 157 days after the submission was received.
What is the product code of K230663?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.