(78 days)
The Diode Laser Body Sculpture Systems is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.
The HS-851 Diode Laser Body Sculpture Systems is a 1060nm Diode Hyperthermic Laser Lipolysis system and utilizes the latest technology for non-invasive body contouring. It applies a 1060nm wavelength laser to target the adipose tissue to reduce stubborn fat in areas such as flank, abdomen, back and thighs. The purpose of the device is to breakdown the fat cells in the target area and in doing so contour the body and reduce the number of fat cells in that area. The proposed device consists of the main unit, control unit with dedicated software and user interface, and the treatment applicators.
The provided text is a 510(k) premarket notification for a medical device called the "Diode Laser Body Sculpture Systems." This document outlines the device's indications for use, its comparison to predicate devices, and the non-clinical testing performed. It explicitly states that clinical testing was not applicable. Therefore, the document does not contain information about the acceptance criteria or a study that proves the device meets those criteria in a clinical setting.
The response to your request will reflect the absence of this information from the provided document.
Acceptance Criteria and Device Performance Study
As per the provided 510(k) summary (K201731), clinical testing for the Diode Laser Body Sculpture Systems was stated as "not applicable." Therefore, the document does not contain information regarding:
- A table of acceptance criteria and reported device performance based on clinical outcomes.
- Sample sizes used for a clinical test set.
- Data provenance (country of origin, retrospective/prospective) for a clinical test set.
- Number of experts and their qualifications used to establish ground truth for a clinical test set.
- Adjudication method for a clinical test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only) performance study.
- Type of ground truth used for performance evaluation (beyond non-clinical safety and performance).
- Sample size for the training set for a clinical performance study.
- How ground truth for a training set was established for clinical performance.
The non-clinical testing primarily focused on electrical safety, electromagnetic compatibility, and biocompatibility to demonstrate substantial equivalence to predicate devices, rather than establishing clinical efficacy or specific acceptance criteria related to fat reduction outcomes through a clinical study.
Summary of Non-Clinical Testing (as provided):
| Category | Test Performed | Result/Compliance |
|---|---|---|
| Electrical Safety & EMC | IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | Met design specification/Complies with standard |
| IEC 60601-1-2:2014 (Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests) | Met design specification/Complies with standard | |
| IEC 60825-1:2014 (Safety of Laser products - Part 1: Equipment classification and requirements) | Met design specification/Complies with standard | |
| IEC 60601-2-22:2007(third edition)+A1:2012 (Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment for use in conjunction with IEC 60601-1:2005 (third edition)+A1:2012) | Met design specification/Complies with standard | |
| Biocompatibility | Cytotoxicity (on material that contacts humans) | Performed (implies satisfactory results to meet risk management processes as per ISO 10993-1, though specific results are not detailed) |
| Skin irritation (on material that contacts humans) | Performed (implies satisfactory results) | |
| Skin Sensitization (on material that contacts humans) | Performed (implies satisfactory results) |
Note: The FDA 510(k) clearance is based on substantial equivalence to predicate devices, which may or may not require new clinical studies if the technological characteristics and indications for use are sufficiently similar and safety/effectiveness can be demonstrated through non-clinical data and comparison to existing devices. In this case, the statement "It is not applicable" for clinical testing indicates that the manufacturer relied on other means (likely benchmarking against predicate devices with established clinical profiles and robust non-clinical data) to demonstrate substantial equivalence.
§ 878.5400 Low level laser system for aesthetic use
(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.