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The Dermatological Diode Laser Systems 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 proposed device, Diode Laser Therapy System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

There are 2 models included, T5 Pro and T8 Pro, the two models have same intended use, mechanism of action, principle and specification, only difference is the configuration.

The main components of proposed device shown as following: Handpiece, Touchscreen, Emergency Switch, Key Switch, Connector, Indicator Lamp, Foot Switch.

This document describes a 510(k) submission for a Dermatological Diode Laser System, which is a medical device for hair removal and permanent hair reduction. The submission aims to demonstrate substantial equivalence to a predicate device.

Key Findings on Acceptance Criteria and Studies:

The submission explicitly states:

• "No clinical study is included in this submission."

This immediately indicates that no study was conducted to prove the device meets specific performance acceptance criteria for hair removal or permanent hair reduction. The acceptance criteria and performance reported in the table below are based on the device's technical specifications and intended use, and the claim of substantial equivalence to a predicate device, rather than on clinical efficacy data.

1. Table of acceptance criteria and the reported device performance:

Since no clinical study was performed, there are no reported clinical performance metrics directly demonstrating hair removal or permanent hair reduction efficacy for this specific device. The acceptance is derived from the device's technical specifications being sufficiently similar to a legally marketed predicate device, and compliance with safety and electrical standards.

2. Sample size used for the test set and the data provenance:

• No test set for clinical performance was used, as no clinical study was performed. Only non-clinical tests (electrical safety, EMC, laser safety, biocompatibility, software validation) were conducted on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication method for the test set:

• Not applicable, as no clinical test set requiring adjudication was used.

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 system for physical hair removal, not an AI-assisted diagnostic or interpretation tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a physical laser system, not an algorithm or AI.

7. The type of ground truth used:

• For non-clinical tests: Ground truth was defined by compliance with established international standards (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, ISO 10993-10) and the device's own design specifications.

8. The sample size for the training set:

• Not applicable. This device is a hardware laser system, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set was used.

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