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The Q-Switched Nd: Y AG Laser System is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesion, incision, ablation, vaporization of soft tissue for general dermatology as follows:

532nm wavelength (nominal delivered energy of 585nm and 650mm with optional dye handpiece):

• Removal of light ink (red, sky blue, green, purple, and orange) tattoo
• Treatment of benign vascular lesions including, but not limited to: telangiectasias,
• Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses
• Treatment of Post Inflammatory Hyper-Pigmentation

1064nm wavelength:

• Removal dark ink (black, blue and brown) tattoo
• Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma.
• Removal or lightening of unwanted hair with or without adjuvant preparation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles.

The Q-Switched Nd: YAG Laser System is based on the Q-Switch Nd: YAG and frequency-double Nd:YAG laser technology. The system is composed of laser generator, articulated arm, laser power supply, cooling system, display and control system,foot switch and others accessories.

The Q-Switched Nd: YAG Laser System produces a pulsed beam of coherent near infrared (1064nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. In addition, two dye handpieces are available that concert the 532nm wavelength to 585nm and 650nm.

The Q-Switched Nd: YAG Laser System includes two models: HS-290K and HS-290EK.

I apologize, but the provided text from the FDA 510(k) summary for the Q-Switched Nd: YAG Laser System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for software-based diagnostic AI.

Here's why and what the document does discuss:

• Device Type: The document describes a Q-Switched Nd: YAG Laser System, which is a physical laser device used for various dermatological and surgical applications (tattoo removal, pigmented lesions, etc.). It is not an artificial intelligence (AI) software or diagnostic imaging device.
• "Acceptance Criteria" in this context: For a physical medical device like a laser, "acceptance criteria" primarily refer to meeting technical specifications (e.g., laser power output accuracy, wavelength precision, pulse duration, electrical safety standards, electromagnetic compatibility). These are shown in the "VII Non-Clinical Testing" section by compliance with IEC standards.
• No AI Study: Since this is not an AI/software device, there is no discussion of:
  • A table of acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC).
  • Sample sizes for test sets or data provenance for AI validation.
  • Number of experts, qualifications, or adjudication methods for AI ground truth.
  • MRMC studies for human reader improvement with AI assistance.
  • Standalone algorithm performance.
  • Ground truth types like pathology or outcomes for diagnostic AI.
  • Training set details for an AI model.

The document explicitly states under "VIII Clinical Testing": "It is not applicable." This means that for the purposes of this 510(k) submission and establishing substantial equivalence for this laser device, a formal clinical study (which would be where you'd typically find performance data against clinical endpoints or, in the case of diagnostic AI, against expert ground truth) was not required by the FDA. The submission relies on non-clinical testing showing compliance with recognized standards and a comparison of technological characteristics to a predicate device.

Therefore, I cannot extract the information you requested based on the provided text. The questions are highly relevant for diagnostic AI medical devices, but the provided document describes a therapeutic laser device.

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Intended Use: Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology. Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.

Specific Indications:

• 1064 nm wavelength
• Tattoo Removal (dark ink: blue and black)
• Dermal Pigmented Lesions
• Nevus of Ota
• Removal or lightening of hair with or without adjuvant preparation.
• Skin Resurfacing for Acne Scars and Wrinkles
• Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength)
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)

532 nm wavelength (nominal delivered energy of 585 nm and 650 nm with the Optional Multilite Dye Laser Handpiece)

• Tattoo removal (light ink: red, sky blue, green)
• Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
• Epidermal Pigmented lesions including but not limited to: cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus
• Skin Resurfacing for Acne Scars and Wrinkles
• Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength)
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)

The RevLite Q-Switched Nd:YAG Laser System with Handpiece Adaptor consists of a electrically powered Console in which laser energy produced within the system is delivered to the tissue by means of an articulated arm, Handpiece Adaptor and specially designed Handpieces. The user activates laser emission by means of a footswitch.

The provided 510(k) Premarket Notification for the Handpiece Adaptor RevLite Q-Switched Nd:YAG Laser System does not contain any information about acceptance criteria or a study proving the device meets said criteria.

Instead, the document focuses on establishing substantial equivalence to a predicate device (RevLite Q-Switched Nd:YAG Laser System with LCD, K083899). The key statement regarding performance is:

"The RevLite Q-Switched Nd:YAG Laser System with Handpiece Adaptor is comparable to its parent predicate device (RevLite Q-Switched Nd:YAG Laser System with LCD) in terms of its intended use, indications for use, technical specifications, operating performance features, and general design features."

Furthermore, it explicitly states:

• Nonclinical Performance Data: None
• Clinical Performance Data: None

This means that the submission relies entirely on the established safety and effectiveness of the predicate device, arguing that the new Handpiece Adaptor does not change the fundamental performance characteristics of the laser system. Therefore, I cannot extract the requested information as it is not present in the provided text.

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The Spectra VRMIII Laser System is 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 Café-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 wrinkles

The Spectra VRMIII Laser System produces a pulsed beam of coherent near infrared (1064 nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. In addition, two dye handpieces are available that convert the 532 nm wavelength to 585 nm and 650 nm. When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid, highly localized temperature increase to the target chromospheres such as melanin and tattoo particles. This increases localized temperature of the chromospheres. The instantaneous temperature increase causes fragmentation of the chromospheres to smaller particles. By directing the beam onto specific tissue locations, using different handpieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. 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.

The provided text is a 510(k) Summary for the Lutronic Corporation Spectra VRMIII Laser System. It is a premarket notification for a medical device seeking substantial equivalence to legally marketed predicate devices. Crucially, this document explicitly states "Performance Data: None presented."

Therefore, based on the provided text, the device did not undergo a study to prove it meets acceptance criteria in the context of clinical performance or effectiveness. The 510(k) process often relies on demonstrating substantial equivalence to existing devices rather than new clinical trials for performance.

Given this, I cannot provide the requested information, but I can elaborate on why:

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

• Cannot be provided. The document states "Performance Data: None presented." This means there are no reported acceptance criteria or reported device performance metrics in this submission.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Cannot be provided. No test set was described as no performance data was presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Cannot be provided. No test set or ground truth establishment was described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Cannot be provided. No test set or adjudication method was described.

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:

• Cannot be provided. No MRMC study or AI component is mentioned. This device is a laser system, not an AI-powered diagnostic tool.

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

• Cannot be provided. This is a laser system, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Cannot be provided. No performance data or ground truth establishment was described.

8. The sample size for the training set:

• Cannot be provided. No training set was described. This is a laser system, not a machine learning model.

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

• Cannot be provided. No training set or ground truth establishment was described.

In summary, the 510(k) summary explicitly states "Performance Data: None presented," indicating that the document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing new clinical performance data from studies.

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