K170709 is an FDA 510(k) clearance for the CURVE Laser System. Classified as Fat Reducing Low Level Laser within the OLI classification (a category for non-invasive low-level laser body contouring systems), Class II - Special Controls.
Submitted by Yolo Medical, Inc. (Surrey, CA). The FDA issued a Cleared decision on June 6, 2017 after a review of 90 days - within the typical 510(k) review window.
This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.
NCT02909790
Completed
Interventional
Industry-sponsored
Study Safety and Effectiveness of CURVE Laser Therapy for Circumference Reduction of the Waistline.
A RandomizEd DoUble Blinded ControllEd Study to Evaluate the Safety and Effectiveness of the CURVE Low Level Laser Therapy (LLLT) for Circumference Reduction of the Waistline.
| Condition studied |
Injury to Subcutaneous Tissue |
| Study design |
Parallel |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Haneef Alibhai, MD |
| Sponsor |
Yolo Medical Inc.
(industry)
|
Started 2016-05-01
→
Primary completion 2016-09-01
Primary outcome
Reduction of girth measurements for the waistline after successful completion of the three (3) week study procedure.
Study completed - no results published.
This trial concluded in 2016 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov