(159 days)
The Diode Laser is intended for use in dermatologic and general surgical procedures.
The Standard Mode is intended for hair removal, permanent hair reduction.
The FHR Mode is intended for hair removal, permanent hair reduction.
The diode laser system is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
The diode laser is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.
The diode laser emits 808nm wavelength laser which is absorbed by melanin and at the same time greatly reduce the absorption by water and haematoglobin. The laser beam penetrates through epidermis into dermis and absorbed by melanin in hair and hair follicle, producing laser photothermal effect, conducting the energy from hair section to hair toot, rising temperature of melanin and decomposing it, thus reaching effect of hair removal.
During treatment, the Sapphire in handpiece assures reliable and constant cooling result for skin surface with the maximum comfort and safety. When the laser system starts to release energy, skin cooling system works automatically. The cooling system reduces the temperature of treatment area and increase treatment comfort.
The proposed device includes power supply system, central control system, cooling system, laser deliver system and safety feature.
The cover material of the proposed device is ABS (Acrylonitrile Butadiene Styrene) plastic. The patient contact components in laser handpiece include supporting plate which is made of stainless steel and crystal which is made of sapphire.
The provided document describes a 510(k) submission for a Diode Laser (model DLH-06) intended for dermatologic and general surgical procedures, specifically hair removal and permanent hair reduction.
Here's an analysis of the provided information concerning acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" for the device's clinical efficacy (e.g., specific percentage of hair reduction deemed acceptable). Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is assessed through bench tests to meet design specifications and compliance with relevant standards.
However, we can infer some "performance characteristics" from the device specifications and the comparison to the predicate device.
| Characteristic | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (Diode Laser DLH-06) |
|---|---|---|
| Safety | Compliance with IEC 60601-1-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2 | Complies with all listed safety standards (IEC 60601-1-1:1988+A1:1991+A2:1995, IEC 60601-2-22: 1995, IEC 60825-1: 2007, IEC 60601-1-2:2007) |
| Biocompatibility | Compliance with ISO 10993-5, ISO 10993-10 | Complies with ISO 10993-5:2009, ISO 10993-10:2002/Amd. 1: 2006 |
| Wavelength | Comparable to predicate (810 nm) | 808 nm (considered similar, 2nm difference not raising new safety/effectiveness issues) |
| Fluence (FHR) | ≤ 10 J/cm² (predicate's SHR Mode) | ≤ 10 J/cm² (FHR Mode) |
| Fluence (Standard) | ≤ 120 J/cm² (predicate's HR Mode) | ≤ 120 J/cm² (Standard Mode) |
| Repetition Rate (FHR) | ≤ 10 Hz (predicate's SHR Mode) | ≤ 10 Hz (FHR Mode) |
| Repetition Rate (Standard) | ≤ 3 Hz (predicate's HR Mode) | ≤ 3 Hz (Standard Mode) |
| Pulse Width (FHR) | ≤ 20 ms (predicate's SHR Mode) | ≤ 20 ms (FHR Mode) |
| Pulse Width (Standard) | 5-200 ms (predicate's HR Mode) | 5-200 ms (Standard Mode) |
| Energy Measurement Stability | Not explicitly stated as "acceptance criteria", but tested for minimal deviation. | -0.03% per working time (Energy measurement comparison between plan to use and leave the factory) |
| Cumulative Measurement Uncertainty | Not explicitly stated as "acceptance criteria", but reported. | U=2%(k=2) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes bench tests to verify design specifications and compliance with standards. It does not describe a clinical study with a "test set" of patients. Therefore, information on sample size for a test set, country of origin, or retrospective/prospective nature of a clinical study is not available in this document. The data provenance is from laboratory/engineering bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical study with a patient "test set" is described, there is no information regarding experts used for establishing ground truth or their qualifications. The "ground truth" here is defined by the technical specifications and adherence to international safety and performance standards for laser devices.
4. Adjudication Method for the Test Set
As no clinical study or test set involving human subjects is described, there is no information on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned or implied. The focus of this submission is on demonstrating substantial equivalence through technical specifications and compliance with standards, not on comparing human reader performance with and without AI assistance. This device is a laser system, not an AI-assisted diagnostic tool.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
This concept is not applicable to the device described. The device is a laser system, not an algorithm, and its operation involves a human operator. The document describes bench tests of the device itself.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Engineering Specifications: The design parameters of the device (wavelength, fluence, spot size, etc.).
- International Standards: Compliance with recognized safety and performance standards for medical electrical equipment and laser products (e.g., IEC 60601 series, IEC 60825-1, ISO 10993 series).
- Predicate Device Characteristics: The established safety and effectiveness characteristics of the legally marketed predicate device (Alma Lasers Modified Diode Laser Module with SHR Treatment Mode). Substantial equivalence is the primary ground for approval.
8. Sample Size for the Training Set
Since no clinical study (and thus no "training set" of patient data for an algorithm) is described, there is no information on the sample size for a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned in the context of an algorithm or clinical study, this information is not applicable. The "ground truth" for the device's development and testing involved adherence to technical specifications, manufacturing standards, and regulatory requirements, as assessed through bench testing and comparison to a predicate device.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.