Slimus
FDA 510(k) K192970 · Hironic Co., Ltd.
510(k) numberK192970
Submission
- Device name
- Slimus
- Applicant
- Hironic Co., Ltd.
Yongin-Si, KR - Received
- October 23, 2019
- Decision date
- December 1, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PKT – Laser For Disruption Of Adipocyte Cells For Aesthetic Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5400
- Specialty
- General, Plastic Surgery
Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
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| K210084 | SilkroGEI · Traditional | 06/03/2022SE |
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Questions and answers
When was Slimus cleared by the FDA?
Slimus (K192970) received a 510(k) decision of Substantially Equivalent on December 1, 2020, 405 days after the submission was received.
What is the product code of K192970?
The FDA product code is PKT – Laser For Disruption Of Adipocyte Cells For Aesthetic Use, a Class II (moderate risk) device regulated under 21 CFR 878.5400.