Diode Laser Body Sculpture System
FDA 510(k) K201731 · Shanghai Apolo Medical Technology Co., Ltd.
510(k) numberK201731
Submission
- Device name
- Diode Laser Body Sculpture System
- Applicant
- Shanghai Apolo Medical Technology Co., Ltd.
Shanghai, CN - Received
- June 24, 2020
- Decision date
- September 10, 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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Questions and answers
When was Diode Laser Body Sculpture System cleared by the FDA?
Diode Laser Body Sculpture System (K201731) received a 510(k) decision of Substantially Equivalent on September 10, 2020, 78 days after the submission was received.
What is the product code of K201731?
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.