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Long pulse Nd:YAG Laser System is intended for use for :
• Benign pigmented lesions such as but not limited to , lemtigos( age spots), solar lentigos( sun spots), café au lait macules, sebortheic karatoses, nevi, chloasma, verucae, skin tags, karatoses, tattoss( significant reduction in the intensity of black and/or blue black tattoos) and plaques.
• Pigmented lesions to reduce lesion size, for patients with lesions that would potiently benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The Long Pulse Nd:YAG Laser System is a flashlamp-excited, Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) laser system. Pulsed laser energy at a nominal wavelength of 10641m. This wavelength causes maximum energy absorption by targeting the treatment area and minimum absorption by surrounding skin structures. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target, to minimize heat transfer to surrounding tissues.
Deeper penetration and a more moderate hemoglobin absorption makes 1064 nm wavelength more useful for the deeper hair follicles and vessels. Further, with the right combination of parameters, the 1064 nm wavelength is also suitable for more superficial hair, telangiectasia and spider veins.
Base on this, Long Pulse Nd: Y AG Laser System is intended for 1) Benign pigmented lesions such as ,but not limited to , lemtigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic karatoses, nevi, chloasma, verrucae, skin tags, karatoses, tattoss (significant reduction in the intensity of black and/or blue black tattoos) and plaques. 2) Pigmented lesion size, for patients with lesions that would potiently benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. 3) Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Nd: Y AG Laser System consists of control system, user interface, power source , laser emission and delivery system, cooling system and safety features

The provided document is a 510(k) summary for a medical device called "Long Pulse Nd:YAG Laser System." It's a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of document focuses on comparing the new device to existing ones rather than detailing a clinical study with acceptance criteria and device performance in the way a clinical trial report would.

Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this 510(k) summary.

Here's what can be extracted and inferred from the document:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance metrics. The document focuses on showing substantial equivalence in intended use, technological characteristics, and principles of operation to a predicate device.
• Reported Device Performance: No clinical performance metrics (e.g., success rates, lesion reduction percentages, complication rates) are reported. The document states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." This implies performance was deemed acceptable if it matched the predicate's capabilities or standards, but specific numbers are absent.

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

• Sample Size for Test Set: Not applicable. This document refers to non-clinical tests (electrical safety, EMC, laser safety standards) and a comparison to a predicate device, not a human clinical test set.
• Data Provenance: Not applicable for a clinical test set. The non-clinical tests were presumably conducted by the manufacturer, Advanced Technology Laser Company, Ltd., based in Shanghai, China.

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)

• Number and Qualifications of Experts: Not applicable. No human expert-adjudicated ground truth data is presented.

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

• Adjudication Method: Not applicable. No human test set requiring adjudication is 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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a laser system, not an AI or diagnostic imaging device that would typically involve human readers interpreting results.

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

• Standalone Performance: Not applicable. This is a physical laser device, not a software algorithm.

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

• Type of Ground Truth: Not applicable for clinical performance. The "ground truth" for the non-clinical tests refers to compliance with established international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This a physical laser system, not an AI/machine learning device that would require or report a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of Information from the Document:

While the document does not contain the specific information requested, it does provide key details about the device and its regulatory submission:

• Device Name: Long Pulse Nd:YAG Laser System (Trade Name: SmoothTouch)
• Manufacturer: Advanced Technology Laser Company, Ltd. (Shanghai, China)
• Regulatory Number: K140249
• Intended Use:
  • Treatment of benign pigmented lesions (lentigos, solar lentigos, café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos - significant reduction in black/blue-black intensity, and plaques).
  • Reduction of pigmented lesion size for aggressive treatment or non-responsive lesions.
  • Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is integral.
• Predicate Device: Gentle YAG Laser System (Candela Corporation), K022923
• Technological Characteristics Comparison (Proposed vs. Predicate):
  • Product Code: GEX (SAME)
  • Regulation Number: 21CFR 878.4810 (SAME)
  • Intended Use: SAME
  • Energy Source: ND:YAG Laser (SAME)
  • Waveform: 1064 nm (SAME)
  • Fluence energy range: up to 600J/cm2 (SAME)
  • Spot size: 1.5mm, 3mm, 8mm, 10mm, 12mm and 3mm*8mm (SIMILAR)
  • Aiming laser: 510nm diode laser (<5mW), Class III (SIMILAR)
  • Beam Delivery: Permanently attached umbilical cable and handpieces (SAME)
• Non-Clinical Test Conclusions: Device met all design specifications and was substantially equivalent to the predicate device in non-clinical tests. It complies with IEC 60601-1, IEC60601-1-2, IEC 60601-2-22, and IEC 60825-1 standards. These standards encompass general requirements for safety, electromagnetic compatibility, particular requirements for laser equipment safety, and safety of laser products related to classification and requirements.
• Regulatory Class: Class II
• Product Code: GEX

This 510(k) submission demonstrates substantial equivalence primarily through technical comparison and compliance with relevant safety standards, rather than direct clinical performance data from a specific study against predefined acceptance criteria.

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eBeam CO2 Laser System are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), general surgery ,gynecology,podiary,dental and otorhinolaryngology

Dermatology, Plastic Surgery and General Surgery procedures including but not limited to:

Laser skin resurfacing

Treatment of furrows and wrinkles

Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation.

Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.

Blepharoplasty

Site preparation for hair transplants

Dental procedure including but not limited to -

Periodontal procedures such as - gingivectomy, removal of hyperplasias gingivoplasty (incision and excision);

Oral Surgery procedures such as - aphous ulcer excision, frenectomy, benign /malignant lesion ablation, operculectomy and homeostasis

Podiatry procedures including but not limited to -

Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.

Otorhinolaryngology (ENT) procedures including but not limited to -

Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps.

Gynecology

Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia.

This device is for prescription use only.

The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device.

eBeam CO2 Laser System is an intelligent sealed-off CO2 laser. eBeam CO2 Laser System delivers laser energy to the treatment site via a 7-joint spring-balanced articulated arm in which mirrors reflect the laser beam along the axis of arms to enter the output device- the specially designed handpiece.

eBeam CO2 Laser System can produce a laser beam with a wavelength of 10.6 m which is effective on all soft tissues, thus it can be used in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic(dermatology and plastic surgery), general surgery, gynecology, podiatry, dental and otorhinolaryngology.

eBeam CO2 Laser System consists of control system, user interface, power supply, laser emission and delivery system, cooling system, safety features and handpieces (including scanning handpiece and normal handpiece).

The provided text describes a 510(k) submission for the "eBeam CO2 Laser System." This submission focuses on demonstrating substantial equivalence to a predicate device and does not involve a study to prove the device meets specific performance acceptance criteria in the way a diagnostic AI/ML device would. Instead, the "acceptance criteria" are based on compliance with established safety standards and the device's functional similarity to the predicate.

Therefore, many of the requested categories (sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment, training set size) are not applicable to this type of regulatory submission and device.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
Not applicable. This device is a surgical laser system, not a diagnostic AI/ML system requiring a test set of data. The "testing" referred to in the document is non-clinical laboratory testing of the device's engineering specifications and compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no "test set" or "ground truth" in the context of expert review of data for this type of device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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 not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this device's regulatory acceptance is its adherence to international safety standards and its functional equivalence to a legally marketed predicate device, confirmed through non-clinical laboratory testing.

8. The sample size for the training set
Not applicable. This device does not use an AI/ML training set.

9. How the ground truth for the training set was established
Not applicable.

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The Q-Switched Nd: YAG 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: Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions Treatment of Lentigines Treatment of Caf6-Au-Lait Treatment of Seborrheic Keratoses Treatment of Post Inflammatory Hyper-Pigmentation Treatment of Becker's Nevi, Freckles and Nevi Spilus

1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos Removal of Nevus of Ota Removal of 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 Q-Switched Nd: YAG Laser System is a new device for 510(k) submission and shares the same indications for use and safety compliance, similar design features and functional features with the predicate device.

The Q-Switched Nd:YAG Laser System (GlobalCure-SC6) delivers laser at two wavelengths of 1064nm and 532nm. The double wavelengths cause maximum energy absorption by targeting the treatment area and minimum absorption by surrounding skin. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target. to minimize heat transfer to surrounding tissues.

The Q-Switched Nd:YAG Laser System covers control system, user interface, power supply, laser emission and delivery system, cooling system and safety features.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Q-Switched Nd:YAG Laser System:

Based on the provided 510(k) summary, the device is a Q-Switched Nd:YAG Laser System. The submission is for a medical device and therefore the acceptance criteria are not clinical performance metrics but rather compliance with design specifications and regulatory standards.

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample size used for the test set and the data provenance:

   • The provided text does not mention any clinical test set involving human subjects or data. The testing discussed is non-clinical laboratory testing to verify design specifications and compliance with standards.
   • The "data provenance" mentioned is compliance with international standards (IEC) and national regulations (US FDA, EU MDD).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not applicable as there is no clinical test set described in the provided document. The "ground truth" for this submission focuses on engineering specifications and regulatory compliance.

3. Adjudication method for the test set:

   • This information is not applicable as there is no clinical test set described.

4. 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, an MRMC comparative effectiveness study was not done. This document describes a laser system, not an AI-assisted diagnostic device, and therefore this type of study is not relevant to this submission.

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

   • No, this is not applicable. The device is a physical laser system, not an algorithm. The "standalone performance" refers to the device's ability to meet its technical specifications and regulatory requirements.

6. The type of ground truth used:

   • For this 510(k) submission, the "ground truth" is defined by established engineering design specifications, international performance and safety standards (e.g., IEC standards), and national/regional medical device regulations (e.g., 21 CFR, MDD). The device's performance against these specifications and standards constitutes the "ground truth" for its safety and effectiveness determination via substantial equivalence.

7. The sample size for the training set:

   • This information is not applicable as there is no discussion of a training set for an algorithm. The device is a physical laser system.

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

   • This information is not applicable as there is no discussion of a training set for an algorithm.

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The ATL Family of CO2 Medical Laser Systems (and the delivery accessories that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

Dermatology, Plastic Surgery and General Surgery procedures including but not limited to -

• A Treatment of furrows and wrinkles
• A Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation,
• A Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
• A Blepharoplasty
• V Site preparation for hair transplants

Dental procedure including but not limited to

• ア Periodontal procedures such as - gingivectomy, removal of hyperplasias, gingivonlasty (incision and excision)

• Oral Surgery procedures such as - aphous ulcer excision, frenectorny, benignimalignant lesion ablation, operculectomy and homeostasis

Podiatry procedures including but not limited to -

• Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.
  Otorhinolaryngology (ENT) procedures including but not limited to -

• ア Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucae vulgares, choanal atresia, LAUP and papillomatosis polyps.
  Gynecology
• V Treatment of condyloma acuminata, cervical intracpithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasja.

The ATL Family of CO2 Medical Laser Systems is a microprocessor-controlled CO2 laser system using a sealed laser tube providing either 15 watts maximum power (ATL-150) or 25 watts maximum power (ATL-250).

The ATL Family of CO2 Medical Laser Systems is intended to be used to deliver 10.6um CO2 light energy in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties.

The ATL Farnily of CO2 Medical Laser Systems covers control system, user interface, power supply, laser emission and delivery system, cooling system and safety features.

This 510(k) summary (K083918) for the ATL Family of CO2 Medical Laser Systems indicates that no clinical studies were required or performed to demonstrate substantial equivalence or meet acceptance criteria. The submission relies entirely on non-clinical testing and comparison to a predicate device.

Therefore, many of the requested details cannot be provided as they pertain to clinical studies.

Here's the breakdown of what can be extracted from the provided document:

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

The document does not provide a table of specific acceptance criteria in terms of performance metrics (sensitivity, specificity, etc.) for the device. Instead, acceptance is based on adherence to recognized standards and verification through laboratory testing that the device met its design specifications and was substantially equivalent to the predicate.

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

• Not applicable. No clinical test set was used. "No Clinical Information is required."

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)

• Not applicable. No clinical test set or ground truth established by experts for clinical performance.

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

• Not applicable. No clinical test set.

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. No AI component. No MRMC study was done. This is a medical laser system, not an AI diagnostic device.

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

• Not applicable. This is a medical laser system, not an algorithm. Performance was evaluated based on meeting design specifications and safety standards.

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

• Not applicable for clinical performance. For non-clinical validation, the "ground truth" was adherence to established engineering standards and design specifications, verified through laboratory testing.

8. The sample size for the training set

• Not applicable. No training set was used as this is not an AI/machine learning device.

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

• Not applicable. No training set.

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The Angelite Family of Intense Pulsed Light Systems (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, various benign pigmented lesions and hair removal as follow:

1. Intense Pulse Light Energy Wavelengths from 400 950 nm are indicated for the treatment of inflammatory acne.
2. Intense Pulse Light Energy Wavelengths from 560 1200 nm are indicated for the treatment of benign pigmented (epidermal and coetaneous) lesions including warts, scars and striae. For the treatment of benign (cutaneous) vascular lesions includes port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melagenna, angiomas and spider anglormas, poikiloderma of civatte, leg veins, facial veins and venous malformations.
3. Intense Pulse Light Energy Wavelengths from 700 1200 nm are indicated for the treatment of unwanted hair (i.e., hair removal).

Angelite Family of Intense Pulsed Light Systems

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Angelite Family of Intense Pulsed Light Systems," indicating its substantial equivalence to a legally marketed predicate device.

The document includes:

• The device name and regulatory information.
• Indications for Use.
• Basic FDA contact and regulatory compliance information.

It does not contain:

• Specific acceptance criteria for the device's performance.
• Details of any study (like sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results) that would demonstrate the device meets acceptance criteria.

The information provided confirms that the device is cleared for market based on substantial equivalence, but it does not elaborate on the specific performance metrics or studies used to establish that equivalence beyond listing the indications for use.

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