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Intended Use:
The EpiLaze Multi-wavelength Laser is intended for use in dermatologic and general surgical procedures.

Indication for Use for the 1064nm wavelength:

• The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) Modes are intended for
• permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen: and
• treatment of Pseudo folliculitis Barbae (PFB).

Indication for Use for the 810nm wavelength:

• The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) . Modes are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
  Indication for use for the 755nm wavelength:
• The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) ● Modes are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
  The STANDARD mode can be used on all skin types (Fitzpatrick I-VI), including tanned skin. The SFT mode can only be used on Fitzpatrick skin type I-IV. Do not use the SFT mode on tanned skin.

The EpiLaze Multi-wavelength Laser is a microprocessor-controlled, user friendly 755nm, 810nm and 1064nm Diode laser system using a sealed diode pack that produces a maximum energy of 120J/cm². The system incorporates a diode pack within each hand piece, and the energy is delivered from the hand piece directly to the desired target. The EpiLaze Multi-wavelength Laser consists of a console, a touch screen user interface, a footswitch and 2 handpieces

The provided text describes the EpiLaze Multi-wavelength Laser, a device intended for dermatologic and general surgical procedures, specifically for permanent hair reduction and treatment of Pseudo folliculitis Barbae (PFB).

The device did not undergo a clinical study to prove its performance against acceptance criteria. Instead, its substantial equivalence to a predicate device (Modified Alma Lasers Soprano XL Family of Multi-application & Multi-technology Platform, Soprano Yag Hand Piece, K170626, referred to as Soprano Ice) was established through a comparison of technical specifications and regulatory compliance.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific acceptance criteria for a clinical study or device performance metrics like sensitivity/specificity are reported, the table below reflects the comparison against the predicate device, which forms the basis of "performance" in this 510(k) submission.

Conclusion from comparison: The technical specifications for the 1064nm wavelength are identical between the EpiLaze and the predicate. For 810nm and 755nm, the specifications are identical for comparable modes (STANDARD/SFT vs HR/SHR). The EpiLaze does not have the "LB mode" present in the predicate and thus does not include indications for treating benign vascular or pigmented lesions. This difference in indications for use is noted but does not prevent substantial equivalence for the shared indications.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. The submission states, "A human clinical study was not required as the device is identical to the predicate device." Therefore, there was no independent test set of patients or data for the EpiLaze device's clinical performance.
• Data Provenance: Not applicable for clinical performance. The data provided focuses on technical specifications and regulatory compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable, as no human clinical study or test set requiring expert ground truth was conducted for this device's 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as no human clinical study or test set was conducted for this device's 510(k) submission.

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 hair removal/dermatological procedures, not an AI-assisted diagnostic or imaging interpretation device.

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

Not applicable. This device is a laser system, not an algorithm. Bench testing was performed to show the difference between set and delivered energy parameters, and software verification and validation were conducted. These are not "standalone algorithm performance" in the context of an AI device.

7. The Type of Ground Truth Used

• For Technical Specifications: The "ground truth" for the EpiLaze's technical specifications was established through internal testing by the manufacturer (Rohrer Aesthetics, LLC) to ensure the device met its design specifications and could be compared to the predicate device's published specifications.
• For Clinical Efficacy/Safety: The "ground truth" is implied to be established by the predicate device's existing clearance (K170626), which presumably had sufficient clinical data or a strong scientific basis to support its indications for use. The EpiLaze's claim of "substantial equivalence" means it is considered to achieve the same clinical effects for comparable indications without new clinical data.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/ML device requiring a training set or ground truth establishment for a training set.

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