(50 days)
The Laser Therapy Device is intended for hair removal, permanent 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 Laser Therapy Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode laser source (808 nm). The laser power is delivered to the treatment area via a laser hand piece. The emission laser is activated by a foot switch and a hand piece. The components of the Laser Therapy Device are mainly including main unit, hand piece, watered cup, overflow tube, foot switch, key, interlock, power cord, fuse, glasses and blindfold, etc.
The proposed Laser Therapy Device is equipped with laser depilation function that is based on the theory of selective photo thermolysis. There is abundant melanin in hair follicle and hair stem. The melanin is distributed amidst the cells between the hair ball substrate and it can be transferred to the structure of hair stems (such as medulla, cortex and hair cuticle). The laser can precisely target at the melanin and apply the depilation treatment selectively. After the melanin absorbs laser energy, the temperature rises, in this way, the surrounding hair follicle tissues are damaged, and the hairs are removed.
This document is a 510(k) premarket notification for a Laser Therapy Device. It does not contain information about a study that proves the device meets specific acceptance criteria in the way typically found for algorithms or AI-driven diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, it demonstrates substantial equivalence to predicate devices through technical comparisons and non-clinical testing against recognized standards.
Therefore, many of the requested fields regarding acceptance criteria and performance studies are not applicable or cannot be extracted from this type of regulatory submission.
Here's a breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
Generally, for a 510(k) for a physical medical device like a laser, acceptance criteria often revolve around meeting recognized safety and performance standards, and demonstrating substantial equivalence to a predicate device in terms of intended use and technological characteristics. The "performance" reported is adherence to these standards and similarity to predicates.
| Acceptance Criteria (Derived from Standards/Predicate Comparison) | Reported Device Performance |
|---|---|
| Electrical Safety: Comply with ANSI/AAMI ES60601-1, IEC 60601-2-22 | Complies with ANSI/AAMI ES60601-1, IEC 60601-2-22 |
| EMC: Comply with IEC 60601-1-2 | Complies with IEC 60601-1-2 |
| Laser Safety: Comply with IEC 60601-2-22, IEC 60825 | Complies with IEC 60601-2-22, IEC 60825 |
| Biocompatibility (Cytotoxicity): No Cytotoxicity | No Cytotoxicity (per ISO 10993-5) |
| Biocompatibility (Sensitization): No evidence of sensitization | No evidence of sensitization (per ISO 10993-10) |
| Biocompatibility (Irritation): No evidence of irritation | No evidence of irritation (per ISO 10993-10) |
| Spot Size Accuracy | Performance Testing for Spot Size Accuracy was conducted. (Result not detailed beyond "met all design specifications") |
| Energy Output Accuracy | Performance Testing for Energy Output Accuracy was conducted. (Result not detailed beyond "met all design specifications") |
| Software Verification and Validation (if applicable) | Conducted per "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", with Moderate level of concern. |
| Intended Use Equivalence: Hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. | "The Laser Therapy Device is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin." Stated as same as predicate. |
| Technological Characteristics Equivalence: Similar fluence, laser wavelength, spot size, pulse duration etc. to predicates. | Detailed comparison table shows substantial equivalence or justified differences for all key parameters. |
2. Sample size used for the test set and the data provenance
- Not applicable / Not explicitly stated. This document describes non-clinical testing (electrical safety, EMC, laser safety, biocompatibility, and performance testing for accuracy), not a clinical trial with a "test set" of patient data. The "test set" in this context refers to hardware tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not explicitly stated. This document covers regulatory compliance for a physical medical device, not a diagnostic algorithm requiring expert "ground truth" labeling of data.
4. Adjudication method for the test set
- Not applicable. This concept primarily applies to clinical studies or algorithm performance evaluations where expert consensus confirms labels.
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
- No. This document is for a laser therapy device, not an AI or diagnostic imaging device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical laser therapy device, not an algorithm.
7. The type of ground truth used
- For the non-clinical tests (e.g., electrical safety, EMC, laser safety, biocompatibility), the "ground truth" is adherence to established regulatory standards (e.g., IEC, ISO) and internal design specifications.
- For the claim of "permanent hair reduction," this definition serves as the clinical outcome benchmark, but no clinical study was included in this submission to demonstrate the proposed device meets this definition. Instead, it relies on substantial equivalence to predicates that are already cleared for this indication.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
Summary of the Study:
The "study" described in the 510(k) submission for the Shenzhen Leaflife Technology Co., Ltd Laser Therapy Device primarily consists of non-clinical testing to demonstrate compliance with recognized medical device safety and performance standards, and a comparison of technological characteristics to legally marketed predicate devices.
- Non-Clinical Tests: These included Electrical Safety (ANSI/AAMI ES60601-1, IEC 60601-2-22), EMC (IEC 60601-1-2), Laser Safety (IEC 60601-2-22, IEC 60825-1), Biocompatibility (ISO 10993-5 for Cytotoxicity, ISO 10993-10 for Irritation and Sensitization), and Performance Testing for Spot Size Accuracy and Energy Output Accuracy.
- Software Verification and Validation: Conducted for the device's software, determining a "Moderate" level of concern.
- Substantial Equivalence Comparison: The document extensively compares the proposed device's intended use, principle of operation, laser type, wavelength, spot size, irradiance, fluence, frequency, and pulse duration to those of two predicate devices (K162659 and K180353).
Conclusion drawn from the study:
The non-clinical tests verified that the proposed device met all design specifications and complied with the listed standards. Based on the comparison and analysis, the proposed device was determined to be "as safe, as effective, and performs as well as the legally marketed predicate devices," thereby establishing substantial equivalence. No clinical studies were included in this submission.
§ 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.