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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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The ACCENTO single laser system is indicated for the following:
755 nm Long pulsed Alexandrite laser
Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions ( such as port of wine stains, hemangiomas, telangiectasias)
Permanent hair reduction is defined as the 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 regime.

The ACCENTO combined laser system is indicated for the following:
755 nm Long pulsed Alexandrite laser
Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions (such as port of wine stains, hemangiomas, telangiectasias)
1064nm Long pulsed Nd: YAG laser
the removal of un-wanted hair reduction, for stable long term or permanent hair reduction and for treatment of PFB to all skin type Fitzpatrick I-VI including tanned skin. Treatment of Photocoagulation and hemostasis of pigmented and vascular lesions such as port wine stain, hemangiomna, warts, telangiectasia, rosacea, venus lake, legveins and spider veins. Coagulation and hemostasis of soft tissue, Benign pigmented lesions such as lentigos (age spot) Solar lentigos ( sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae skin tags, keratoses, tattoo reduction (dart color) and plaques. Pigmented lesions to reduce lesion size and patients with lesions, reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of scar, Treatment of wrinkle.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, 12, months after the completion of a treatment regime

The ACCENTO Dual device are contained two separate laser heads 755nm long pulsed Alexandrite and 1065nm Nd: YAG laser. The output of each laser head is optically combined on the laser rail to delivery same beams path. This single delivery system can obtain either 755nm or 1064nm wavelengths.
The LED touch screen equipped in Control panel to adjust parameters easily Each laser heads has self contained circulation water system to cool system and laser head fully using distilled water at a controlled temperature. The ACCENTO laser system delivers laser energy with various pulse durations from 0.2ms to 350ms. The output of this laser is delivered to the area of treatment by means of lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end.
A trigger switch( Finger or Foots pedal) is used to control the delivery of laser pulse. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be deliver repetitively as long as the switch is depressed at repetition rates up to 10 pulses per second depending on the chosen pulse duration Energy from the laser is directed to the target area via optical fiber handpiece.
The Dynamic Cooling system provides a short burst of Cryogen spray prior to firing the laser pulse. The Energy is delivered via optical fiber to handpiece with a spot size 2, 3, 5, 8,10,12,18, 20mm diameter circular beam on the skin. Operator may select parameters as desired fluence and repetition rate, and operated using touch screen and display panel
This device consist of
Power supply and modulator system Optical laser Hand pieces and delivery system Circulator system Software control system, Dynamic cooling system, LED control panel
ACCENTO single device are contained 750nm Alexandrite laser only, and provided it optionally to treat related indication.
This device also equipped with safety interlock systems to protect patients and user

The provided document is a 510(k) premarket notification letter from the FDA to Bison Medical Co Ltd regarding their ACCENTO Dual/single Laser. This document is a regulatory approval and does not contain the results of a study proving the device meets specific acceptance criteria in the way a clinical trial report would.

Here's why and what information can be extracted:

• No Acceptance Criteria or Performance Study: The letter explicitly states: "Clinical and Non-Clinical performance test data was not provided in this submission." (Page 5, Section 6). This means there is no study described within this document showing the device's measured performance against a set of acceptance criteria.
• Basis for Clearance: The device received clearance based on substantial equivalence to a predicate device (K130199 CLARITY LPC Lutronic Corp). Substantial equivalence means the new device is as safe and effective as a legally marketed device. This often relies on design, technological characteristics, and intended use being similar, along with adherence to recognized safety standards.
• Mentioned Standards: The document lists several standards the device was manufactured in accordance with (IEC60601-1, IEC60601-1-2, IEC60601-2-22, IEC60825-1). These are safety and electromagnetic compatibility standards, not performance criteria for therapeutic efficacy.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from this document because that information is not present.

However, I can provide information relevant to your other points by indicating what is not present or by describing the basis for clearance:

1. Table of Acceptance Criteria and Reported Device Performance

• Not provided in this document. The submission explicitly stated that "Clinical and Non-Clinical performance test data was not provided in this submission." The device was cleared based on substantial equivalence to a predicate device, not on direct performance data against specific acceptance criteria presented here.

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

• Not applicable/Not provided: No test set data or sample size information is available in this document as performance data was not submitted.

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

• Not applicable/Not provided: No test set was detailed in this filing.

4. Adjudication Method for the Test Set

• Not applicable/Not provided: No test set was detailed in this filing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: A MRMC study was not described or required for this 510(k) clearance, as clinical performance data was not provided.

6. Standalone (Algorithm Only) Performance Study

• No: This device is a laser surgical instrument, which does not involve an algorithm for standalone performance evaluation in the typical sense (e.g., AI diagnostics). Performance data, generally, was not provided.

7. Type of Ground Truth Used

• Not applicable/Not provided: As performance data was not submitted, no ground truth was established or used in this filing. The clearance hinged on substantial equivalence to a predicate device.

8. Sample Size for the Training Set

• Not applicable/Not provided: This document relates to a physical laser device and its regulatory clearance; it does not involve training sets as would be used for AI/machine learning models.

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

• Not applicable/Not provided: This document does not describe a training set or its ground truth establishment.

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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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