Search Results

The device is intended for use in dermatologic and general surgical procedures.

The simultaneous triple wavelength handpiece is intended for use in dermatology procedures requiring coagulation. The indications for use for the Triple wavelength handpiece include: Benign vascular and vascular dependent lesions removal.

The indications for use for the handpiece of 1064nm include:

• -The Hair Removal is 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.
• Treatment of Pseudo folliculitis Barbae (PFB) -
• Use on all skin types (Fitzpatrick I-VI), including tanned skin. -

The indications for use for the handpiece of 808 nm include:

• -The Hair Removal (HR) is 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 treatment of benign vascular and pigmented lesions. -
• -Use on all skin types (Fitzpatrick I-VI), including tanned skin.

The indications for use for the handpiece of 755 nm include:

• The Hair Removal (HR) is 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 treatment of benign vascular and pigmented lesions. -
• -Use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Quadruple Laser System consists of the main unit and a hand piece. The system uses a diode laser as an active medium placed in an optical cavity to produce amplified beam. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit.

The Laser treatment device is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective photothermolysis. The wavelength of 808nm, 755, and 1064nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system.

The proposed device includes power supply system, control system, control system, cooling system, laser system.

The 755nm, 808 nm, 1064nm handpieces with different treatment sizes are available for different models.

The Quadruple Laser System (Models: CPMT ARES, CPMT NEMESIS, CPMT NYX PLUS, CPMT GRACE PLUS) obtained 510(k) clearance (K222915) through demonstrating substantial equivalence to predicate devices (K211722 and K172193). The review was based on non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical performance data (biocompatibility, electrical safety, EMC, laser safety) rather than clinical study data involving patient samples. Therefore, the concept of a "test set" in the context of clinical images or patient data is not applicable here.

• Sample Size: Not applicable for non-clinical testing.
• Data Provenance: The document does not specify the country of origin for the non-clinical test data. It only states that the testing was performed. These tests are typically conducted in a laboratory setting.
• Retrospective/Prospective: Not applicable for non-clinical testing.

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

Not applicable. The non-clinical tests rely on established international standards (ISO, IEC) rather than expert consensus on ground truth for individual cases. The "ground truth" for these tests is defined by the technical specifications and criteria within the respective standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations (e.g., of medical images). This document describes non-clinical engineering and safety tests, which do not involve such adjudication.

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 MRMC comparative effectiveness study was done. This device is a laser system for dermatologic and general surgical procedures, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a hardware laser system, not a software algorithm.

7. The Type of Ground Truth Used

For biocompatibility, electrical safety, EMC, and laser safety, the "ground truth" is defined by the specific requirements and test methods outlined in the cited international standards (ISO 10993-1, IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2). Compliance with these standards indicates that the device is safe and performs as intended.

8. The Sample Size for the Training Set

Not applicable. This device is a physical laser system, not an AI model that requires a training set.

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

Not applicable. As this is not an AI device, there is no training set or associated ground truth establishment process for training.

Ask a specific question about this device