(86 days)
The Diode Laser Therapy System is intended for hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The proposed device, Diode Laser, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
Function module description
a. Power System
b. Microprocessor Control System
c. Operation Display System
d. Cooling System
e. Handpiece module
The provided text is a 510(k) premarket notification for a medical device, specifically a "Diode Laser Therapy System" intended for hair reduction. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data to prove the device meets specific acceptance criteria in the way a new, novel device might.
Therefore, the document explicitly states: "No clinical study is included in this submission." As such, there is no study described that proves the device meets specific acceptance criteria in terms of clinical performance metrics. The acceptance criteria for this submission are primarily focused on "substantial equivalence" to a predicate device based on technical characteristics and safety standards.
However, I can extract the information relevant to the assessment requested, based on the non-clinical tests performed and the comparison to an existing predicate device.
Here's the information structured as requested, noting the limitations due to the nature of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are derived from the comparison to the predicate device and the adherence to recognized safety standards. Performance is indicated by matching the predicate's technical specifications and safety compliance.
| Acceptance Criterion (Based on Substantial Equivalence and Safety Standards) | Reported Device Performance (Diode Laser Therapy System) |
|---|---|
| Intended Use Equivalence: Hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin, with permanent reduction measured at 6, 9, and 12 months post-treatment. | Meets: Intended use is identical to the predicate device. |
| Product Code: GEX (Laser Surgical Instrument) | Meets: Product Code is GEX. |
| Regulation Number: 21 CFR 878.4810 | Meets: Regulation Number is 21 CFR 878.4810. |
| Principle of Operation: Diode Laser | Meets: Operated by Diode Laser. |
| Laser Type: Diode Laser | Meets: Diode Laser. |
| Laser Classification: Class IV | Meets: Class IV. |
| Laser Wavelength: 808 nm | Meets: 808 nm. |
| Fluence Range: 5-40 J/cm² | Meets: 5-40 J/cm². (It is explicitly stated "They are exactly same"). |
| Patient Contact Materials Biocompatibility: No cytotoxicity, no evidence of sensitization, no evidence of irritation from handpiece tip. | Meets: Handpiece tip materials show no cytotoxicity, sensitization, or irritation, complying with ISO 10993-5 and ISO 10993-10. |
| Electrical Safety: Compliance with IEC 60601-1 and IEC 60601-2-22. | Meets: Complies with IEC 60601-1 and IEC 60601-2-22. |
| EMC (Electromagnetic Compatibility): Compliance with IEC 60601-1-2. | Meets: Complies with IEC 60601-1-2. |
| Laser Safety: Compliance with IEC 60601-2-22 and IEC 60825-1. | Meets: Complies with IEC 60601-2-22 and IEC 60825-1. |
| Other Parameter Equivalence: (Spot Size, Pulse Duration, Frequency, Power Supply, Dimension, Weight) | Discussion: Differences exist but are deemed not to affect safety and effectiveness, based on non-clinical testing and comparison to reference devices for safety margins (e.g., maximum pulse duration). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: No clinical test set data is provided as "No clinical study is included in this submission." The "test set" for this 510(k) relies on the general comparison of technical specifications and safety test results against established standards and predicate devices.
- Data Provenance: The data provenance for non-clinical tests (electrical safety, EMC, laser safety, biocompatibility) would be from laboratory testing performed on the Diode Laser Therapy System (LFS-K8) by San He Lefis Electronics Co., Ltd. The document does not specify the country of origin for these specific test results, but the manufacturer is based in China. These non-clinical tests are inherent to the device itself and are essentially prospective in the sense that they are performed on the device being submitted for clearance to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As no clinical study was performed, there was no "test set" in the sense of patient data requiring expert ground truth establishment for clinical endpoints.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set and no expert adjudication for clinical endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a laser therapy system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a non-AI hardware medical device.
7. The Type of Ground Truth Used
The "ground truth" in this 510(k) submission relates to:
- Established Standards: Ground truth for safety and performance parameters is defined by recognized international standards (e.g., IEC 60601 series, ISO 10993 series, IEC 60825-1).
- Predicate Device Specifications: The technical specifications and established safety profile of the legally marketed predicate device (K181019) serve as a comparative ground truth for evaluating substantial equivalence.
- There is no pathology, outcomes data, or expert consensus used for clinical ground truth in this submission because clinical studies were explicitly excluded.
8. The Sample Size for the Training Set
Not applicable. No AI/machine learning component requiring a training set. This is a physical medical device.
9. How the Ground Truth for the Training Set was Established
Not applicable. No AI/machine learning component requiring a training set.
§ 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.