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The LUCID O-PTP Nd : YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength (nominal delivered energy of 585 nm with optional dye hand pieces): Tattoo removal light ink (red, tan, purple, orange, sky blue, green), Removal of Epidermal Pigmented Lesions, Minor Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Post Inflammatory Hyper-Pigmentation, Treatment of Becker's Nevi, Freckles and Nevi Spilus

1064nm Wavelength:

Tattoo removal: dark ink ( black, blue, brown) Removal of Nevus of Ota Removal or lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi, Melasma, Skin resurfacing procedures for the treatment of acne scars, wrinkle

The LUCID O-PTP O-Switched Nd: Y AG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and optional 2 dye Handpieces are available that convert the 532nm wave length to 585nm and 650nm, using different Handpiece able to control various treatment fluence.

this device is non-contacted mode and consists of main function,

laser tube ; placed in the mixed crystals of copper pipe to the heater and produces a laser beam,

Resonator : amplifies the beam, through the Xe-gas contained lamp : Xe-gas contains high pressure lamp to increase specific laser beam lamp

This converted light energy creates the ND:YAG crystal and exhaust from the crystal is amplified into a specific wave length. Laser energy produced is delivered to the Tissue by means of an articulated arm and a specially designed multi spot Hand Piece.

The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.

This system also consist of

Optic main Bench assembly, Articulated Arm Hand pieces, LCD control panel, Cooling system, Foot Pedal Switch

The provided text is a 510(k) summary for the LUCID Q-PTP / HWA 55 laser system. It explicitly states in section 6, "Performance test," that "Clinical and Non-Clinical performance test data was not provided in this submission."

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as no such data is present in the provided document.

The document focuses on demonstrating substantial equivalence to a predicate device (K113588, Spectra Nd:YAG by Lutronic Corp) based on similar design, construction, energy rates, pulse duration, optional dye handpiece, cooling system, and intended use, as well as adherence to various safety standards (IEC60601-1, IEC60601-1-2, IEC60601-2-22, IEC60825-1).

Without a performance study, it's impossible to provide the requested information such as acceptance criteria, reported performance, sample sizes, ground truth establishment, or multi-reader multi-case study results.

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RUBY STAR Laser Q -switched 694mm Ruby laser system is indicated for cutting, vaporization, and ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions.

RUBY STAR Q-switched laser system are emitting a beam of coherent light at 694nm with 25-30ns Pulse width, and 0.1 - 200j/cm2 Energy fluence via 7-Articulated arm and consist of

• • An articulated arm delivery systems terminated in a hand piece.
• • Electronic power supply and interface circuitry
• • Optical chamber with laser rod and cavity optics with cooling system.
• • LCD color touch screen with foot pedal switch.
    Laser energy produced is delivered to the Tissue by means of an articulated arm.
    The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch.

The provided document is an FDA 510(k) summary for the "RUBY STAR" laser system. Unfortunately, it states that "Clinical and Non-Clinical performance test data was not provided in this submission."

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and the study that proves the device meets those criteria. The document explicitly mentions the absence of such data in point 6, "Performance test."

However, I can extract other relevant information from the document:

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

• Acceptance Criteria: Not explicitly stated as performance metrics in the document. The submission relies on substantial equivalence to a predicate device and compliance with general safety standards.
• Reported Device Performance: No clinical or non-clinical performance test data was provided in the submission. The device is described as emitting a beam of coherent light at 694nm with 25-30ns Pulse width, and 0.1 - 200j/cm2 Energy fluence. These are technical specifications, not performance outcomes against acceptance criteria.

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

• Sample Size: Not applicable, as no performance test data was provided.
• 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 performance test data was provided.

4. Adjudication method for the test set:

• Not applicable, as no performance test data was provided.

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 study was done, as no performance test data was provided. The device is a laser system, not an AI-assisted diagnostic tool.

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

• No standalone performance study was done, as no performance test data was provided. The device is a laser system, not an algorithm.

7. The type of ground truth used:

• Not applicable, as no performance test data was provided.

8. The sample size for the training set:

• Not applicable, as no performance test data was provided and the device is not an AI/machine learning model that typically requires a training set.

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

• Not applicable.

Additional information from the document:

• Predicate Device: K990902 MLT R694 Medical laser Technologies. The submission claims substantial equivalence based on characteristics such as Design, Construction, Energy, Repetition rate, Cooling System, and Intended use of wave length 694nm.
• Standards Complied With: The device was manufactured in accordance with IEC60601-1 (general requirements for basic safety and essential performance), IEC60601-1-2 (EMC test), IEC60601-2-22 (particular requirements for safety of diagnostic and therapeutic laser), and IEC60825-1 (equipment classification and requirement). This indicates compliance with safety and electrical standards, not necessarily clinical performance.
• Intended Use: Cutting, Vaporization, Ablation of Soft Tissue, including Tattoo Removal and treatment of Benign Pigmented Lesions.

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