Regulatory · 2018
FDA 510(k) market clearance — overall body circumference reduction
US Food and Drug Administration — Erchonia Corporation
All clinical evidence
Summary
FDA market clearance for the use of the green laser in overall body circumference reduction of the waist, hips and thighs, including patients with a BMI up to 40.
Key findings
- First clearance of its kind for overall body circumference reduction
- Includes higher-BMI patients up to BMI 40
- Supported by blinded, placebo-controlled clinical data
Clinical takeaway
Regulatory clearance is grounded in blinded clinical trial evidence, not marketing claims.
Study detail
- Design
- 510(k) market clearance
- Participants
- Regulatory submission
- Published
- US Food and Drug Administration, 2018
- Category
- Regulatory
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