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The Diode laser 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.

Diode laser device consists of a main unit, a handheld, a foot switch and a power cord.

Device composition and handle characteristics: The device includes a handle with a single-band 808nm semiconductor laser, and the semiconductor lasers of the handle are powered by the laser power supply in the host to emit the laser of the corresponding wavelength.

Working principle of semiconductor laser: Semiconductor laser uses semiconductor materials of different doping types as laser working substance, uses natural cleavage surface to form resonant cavity for laser oscillation and amplification, and adds forward voltage to PN junction area of semiconductor laser to form particle number inversion of non-equilibrium carrier between conduction band and valence band of semiconductor substance. When a large number of electrons and holes in particle number inversion state are recombined, excess energy will be released, and these energies will be expressed in the form of photons, that is, laser is formed. Due to resonance amplification of cleavage surface resonant cavity, stimulated feedback is realized, so that laser can be directionally emitted and output from semiconductor laser.

This 510(k) clearance letter and summary primarily focus on demonstrating substantial equivalence to a predicate device, which is typical for Class II medical devices. The information provided does not contain a detailed study report with specific acceptance criteria related to a performance study for the device's efficacy (hair removal/reduction). Instead, it relies on comparison to a predicate device and adherence to recognized standards for safety and performance.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the context of a clinical or performance study with numerical targets for efficacy (e.g., a certain percentage of hair reduction). Instead, it relies on demonstrating substantial equivalence to a predicate device that is already legally marketed for the same indication. The "performance" assessment is based on the similarity of technical specifications and the successful completion of non-clinical tests to applicable standards, ensuring safety and basic functionality.

• Spot Size: Different, but argued not to affect safety and effectiveness, only treatment area.
• Fluence: Different from the primary predicate but similar to a reference device (K241642), ensuring effectiveness is "not affected." Safety argued to be no problem due to lower max fluence than the predicate.
• Dimension/Weight: Different but argued not to affect safety/effectiveness and comply with mechanical performance standards. |
  | Safety Testing | Compliance with recognized safety standards. | The device passed non-clinical tests verifying compliance with IEC 60601-1, IEC 60825-1, IEC 60601-2-22, ISO 10993-10, ISO 10993-23, ISO 10993-5, and IEC 60601-1-2. These standards cover general safety, laser safety, specific laser equipment safety, biocompatibility (skin sensitization, irritation, cytotoxicity), and electromagnetic compatibility. |

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

The document explicitly states: "No clinical study is included in this submission."

Therefore:

• Sample size for the test set: Not applicable (no clinical test set was used for this submission).
• Data provenance: Not applicable.

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 study or test set with expert-established ground truth was part of this submission. The "ground truth" for clearance in this context is established by the FDA's acceptance of substantial equivalence to an already cleared device, which presumably had clinical data at the time of its own clearance.

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 for hair removal, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.

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

Not applicable. This is a physical medical device (diode laser), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the purpose of this 510(k) submission, the "ground truth" for the device's indications for use and general safety/effectiveness is implicitly the regulatory clearance and established performance of the predicate devices. The applicant is demonstrating that their device is sufficiently similar to these predicates to be considered equally safe and effective.

8. The sample size for the training set

Not applicable, as no clinical study was conducted. There is no "training set" in the context of this 510(k) submission for efficacy.

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

Not applicable, as no clinical study or training set was used.

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