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The Tri-Beam Nd:YAG Laser System in indicated for: - the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with optional dye handpieces):

-Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)

-Removal of Epidermal Pigmented Lesions

-Removal of Minor Vascular Lesions including but not limited to telangiectasias

-Treatment of Lentigines

-Treatment of Caff-Au-Lait

-Treatment of Seborrheic Keratoses

-Treatment of Post Inflammatory Hyper-Pigmentation

-Treatment of Becker's Nevi, Freckles and Nevi Spilus

1064nm Wavelength:

-Tattoo removal: dark ink (black, blue and brown)

-Removal of Nevus of Ota

-Removal or lightening of unwanted hair with or without adjuvant preparation.

-Treatment of Common Nevi

-Skin resurfacing procedures for the treatment of acne scars and wrinkle

The E-Beam Nd:YAG Laser System is a O-Switch laser with wavelengths of 1064nm and 532nm. Optional Dye attachments to the handpiece add additional wavelengths of 585nm and 650nm. This system consists of main body, color touch screen, articulated arm hand-piece and Foot switch.

The E-Beam Nd:YAG Laser System can also be used in a long pulse mode.

Here's a breakdown of the acceptance criteria and the study information for the E-Beam Nd:YAG Laser System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that this 510(k) summary does not provide explicit acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for clinical outcomes. Instead, the "acceptance criteria" are implied through the direct comparison of technical specifications to a predicate device, aiming for substantial equivalence. The reported device "performance" is, therefore, the matching of these technical specs to the predicate.

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

• The document explicitly states "None" for "Performance Data: Results of Clinical Study".
• Therefore, there is no test set sample size and no data provenance (country of origin, retrospective or prospective) for a clinical study. The submission relies solely on technical comparison for substantial equivalence.

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

• Since no clinical study was performed, there was no ground truth established by experts for a test set.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical study or test set 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 is a laser device, not an AI diagnostic or assistive device that would involve human "readers" or an "effect size of human improvement with AI." The document explicitly states "None" for clinical study results.

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

• Not applicable. This is a medical device (laser system), not an algorithm or AI. The concept of "standalone performance" in this context refers to the device's technical specifications and intended functionality, which were evaluated through direct comparison to the predicate.

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 performance is established by its technical specifications directly matching or being functionally equivalent to the technical specifications of the legally marketed predicate device (Lutronic Spectra Laser System K113588). No clinical ground truth (e.g., pathology, outcomes data) based on human subjects was used.

8. The sample size for the training set

• Not applicable. This is not an AI or machine learning device that would require a "training set."

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

• Not applicable. As there is no training set mentioned or implied.

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