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The IDAS laser system is intended for use for Aesthetics: vascular lesions, spider veins, spider naevi, teleangiectasis, red superficial veins of the legs and face, pigmented lesions (e.g. café-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.

The IDAS laser system (532 nm) is used for the treatment of superficial vascular lesions and for pigmented lesions. The laser radiation emitted by this type of faser system has a wavelength of 532 nm. Radiation of this wavelength is characterized by a particularly strong absorption by hemoglobin and melanin. The radiation emitted by the laser penetrates into the human skin 0.1 - 1 mm thus being able to locally heat up even deeper-lying target structures which consequently leads to the desired effect. The laser system (532 nm) can be used in two different operating modes: In the "cw" (= continuous wave) mode or in the "pulsed" operating mode. Beam transmission is ensured by a fiber and a handpiece with different adapters which are used to adjust the spot diameter on the skin. Beam transmission, however, can be also effected via a bare fiber. While the parameter wavelength is specified by the device, spot size, fluence or power, pulse duration, frequency and the intensity of the aiming beam can be selected by the treating physician for optimal adjustment to individual requirements.

The provided text states, "6. Performance Data None presented." Therefore, no information regarding acceptance criteria, device performance, sample size, ground truth, or study details is available in the document.

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The BURANE is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general and all surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The BURANE is indicated for use in skin resurfacing. The BURANE is indicated for use in medicine and surgery, in the following medical specialities: Dermatology, Plastic Gastroenterology, ENT, Thoracic Surgery, Oral & Maxillofacial Surgery, Ophtalmology & Podiatry.

Aesthetic Surgery
Skin resurfacing and treatment of wrinkles.

Dermatology/Plastic Surgery
Indications include, epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers.

Gastroenterology

General Surgery
The Er:YAG laser is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during general surgery application where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation.

Genitourinary
Indications include lesions of the external genitalia, urethra and anus, penis, condyloma acuminata, giant perineal condyloma (Includes condyloma actinoma), vulvar lesions, polyps and familial polyps of the colon.

Gynecology
Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.

ENT
Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia.

Oral/Maxillofacial
Indications include benign oral tumors, oral and glossal lesions and gingivectomy.

Ophtalmology
Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.

Podiatry
Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.

BURANE is a Er:YAG laser system for dermatological interventions and for aesthetic laser applications. The BURANE has an Ablation Mode and a Coagulation Mode. Furthermore, the laser system enables a quick, precise ablation with minimal thermal damage. Thus an optimal wound healing process is achieved and thermal tissue admission is minimized. This is due to the BURANE's wavelength of 2.94 µm, which has an absorption maximum in water and is absorbed very well by tissue water. The thermal damage zone is thus minimized. While the parameter wavelength is specified by the device, spot size, laser energy, pulse sequence, and coagulation function can be selected by the treating physician for optimal adjustment to individual requirements.

The provided FDA 510(k) summary for the BURANE laser system does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The "Performance Data" section explicitly states "None presented." ([3]). This indicates that the submission did not include a study demonstrating specific quantitative performance metrics against pre-defined acceptance criteria.

Therefore, I cannot populate the requested tables and answer most of the questions, as the information is not present in the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

1. Table of acceptance criteria and the reported device performance:

• Cannot be provided. The document states "Performance Data: None presented."

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 performance study was presented, so there is no test set or related data.

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 performance study was presented.

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

• Cannot be provided. No performance study was presented.

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. This device is a laser system, not an AI or imaging device with human readers. No MRMC study would be applicable or expected for this type of device.

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

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

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

• Cannot be provided. No performance study was presented.

8. The sample size for the training set:

• Cannot be provided. No performance study involving a training set (as understood in the context of AI/algorithms) was presented. The device itself (a laser) would have gone through internal development and testing, likely involving various materials and potentially animal/cadaveric models, but this is not typically referred to as a "training set" in this context nor is it detailed in this 510(k) summary.

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

• Cannot be provided. No performance study was presented.

Summary of what the document does provide:

• Device Name: BURANE ([1])
• Device Type: Er:YAG laser system for dermatological interventions and aesthetic laser applications, with ablation and coagulation modes. ([1])
• Indications for Use: Detailed for various medical specialties including Aesthetic Surgery, Dermatology/Plastic Surgery, Gastroenterology, General Surgery, Genitourinary, Gynecology, ENT, Oral/Maxillofacial, Ophthalmology, and Podiatry. It is intended for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. ([1], [5], [6])
• Predicate Devices: Several other laser systems are listed for substantial equivalence. ([1])
• Regulatory Status: Cleared via 510(k), classified as a Class II device (Laser surgical instrument for use in general and plastic surgery and in dermatology). ([3])

The absence of performance data in this 510(k) summary suggests that the FDA's substantial equivalence determination was primarily based on the similarity of the BURANE device's technological characteristics, indications for use, and safety profile to already legally marketed predicate devices, rather than a new clinical performance study.

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The AURIGA Holmium Laser system is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (f. e. strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (f. e. DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery.

The AURIGA is a pulsed solid-state Holmium YAG-Laser System with a wavelength of approx. 2080 nm. The system is suitable for interdisciplinary use in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (f. e. strictures) , ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (f. e. DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery.

The provided document is a 510(k) summary for the AURIGA Holmium Laser System. It focuses on establishing substantial equivalence to predicate devices and detailing the device's intended use. Crucially, the document explicitly states "Performance Data not presented" and does not include any studies proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document only provides the following:

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

• No acceptance criteria or reported device performance are presented in the document. The document states "Performance Data not presented."

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

• Not provided. No test set data or provenance is mentioned.

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 provided. No information on ground truth establishment for a test set is present.

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

• Not provided. No adjudication method for a test set is mentioned.

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 or reported. This device is a surgical laser, not an AI-assisted diagnostic tool, so such a study would not be applicable in this context.

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

• Not applicable. This device is a surgical laser, not an algorithm.

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

• Not provided. No ground truth information is available as no performance data or studies are presented.

8. The sample size for the training set:

• Not provided. No training set is mentioned as no algorithm or AI is discussed.

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

• Not provided. No training set or ground truth establishment for it is mentioned.

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The BURANE XL is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in any surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The BURANE XL is indicated for use in skin resurfacing. The BURANE XL is indicated for use in medicine and surgery, in the following medical specialities: Dermatology, Plastic and Aesthetic Surgery, Gastroenterology, ENT, Thoracic Surgery, Oral & Maxillofacial Surgery, Ophtalmology & Podiatry.

Aesthetic Surgery
Skin resurfacing and treatment of wrinkles.

Dermatology/Plastic Surgery
Indications include, epidermal nevi, telangiectasia, spider veins, actinic keratoses, scar revision, debulking benign tumors, decubitis ulcers.

Gastroenterology

General Surgery
The Er:YAG laser is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during general surgery application where skin and subcutaneous tissue is encountered. Indications include excision of external tumors and lesions, complete or partial tissue dissection, excision of external tumors and lesions, tissue ablation and/or vessel coagulation.

Genitourinary
Indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (includes condyloma acuminate, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon.

Gynecology
Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.

ENT
Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia.

Oral/Maxillofacial
Indications include benign oral tumors, oral and glossal lesions and gingivectomy.

Ophtalmology
Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.

Podiatry
Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.

BURANE XL is a Er:YAG laser system for dermatological interventions and for aesthetic laser applications. The triple mode technology makes BURANE for aesthetic ideal applications. The Coagulation Mode for different AL an export dother the Ablation Mode for classical ablation procedures, and the combination of both techniques. Furthermore, the laser system enables a quick, precise ablation with minimal thermal tissue damage. Thus an optimal wound health process is achieved. -- the risk of scar formation is minimized. This is due to the BURANE XL's wavelength of 2.94 pm, which has an absorption in water and is thermal damage zone is thus minimized. While the parameters wavelength and pulse form are specified by the device, spot size, laser energy, pulse sequence, and coagulation function can be selected by the treating physician for optimal adjustment to individual requirements.

The provided text is a 510(k) summary for the WaveLight Burane XL device, primarily focusing on its substantial equivalence to predicate devices and its intended uses. It does not contain information about specific acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot populate the table or answer most of the questions as the required information is not present in the provided document.

Here's what can be stated based on the text:

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

• Information not provided. The document states "Performance Data None presented."

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

• Information not provided. The document states "Performance Data None 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)

• Information not provided. The document states "Performance Data None presented."

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

• Information not provided. The document states "Performance Data None presented."

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

• Information not provided. The document states "Performance Data None presented." This device is a laser system, not an AI-assisted diagnostic tool, so an MRMC study is highly unlikely to be relevant.

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

• Information not provided. The document states "Performance Data None presented." This device is a laser system, not an algorithm, so a standalone algorithm performance study is not relevant.

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

• Information not provided. The document states "Performance Data None presented."

8. The sample size for the training set

• Information not provided. The document states "Performance Data None presented."

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

• Information not provided. The document states "Performance Data None presented."

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1. In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue. This includes the removal of tattoos and treatment of benign pigmented lesions.
2. In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.

The SINON is a 694 nm Ruby laser system which can be operated in two different modes. The quality-switch or Q-switch or QS Operating Mode is characterized by extremely short pulse widths (ns = 10 °s) and high peak power (MW = 106 W). The QS Operating Mode in the SINON is used for the removal of tattoos and treatment of pigmented lesions. The second mode is the Free-Running Operating Mode which is used for the removal of hair.

The provided text is a 510(k) Summary of Safety and Effectiveness for the WaveLight SINON laser system. It describes the device, its indications for use, and a comparison to predicate devices, but it explicitly states that no performance data is presented. Therefore, I cannot extract the requested information to describe acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document states:
"6. Performance Data
None presented."

This means that the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Information on experts or ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone performance data.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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1. The ARION Alexandrite Laser is intended for use in dermatology for hair removal for skin types Fitzpatrick I - IV.

The ARION is a 755 nm solid-state long-pulsed Alexandrite laser system. The beam is directed to the treatment area by a transmission system which is connected to the laser device. The EPI Zoom Ax transmission system consists of a hand piece attachment with a firmly attached fiber and a hand piece. The hand piece insert can be moved within the hand piece and determine the application and parameter ranges. The hand piece insert in the transmission system hand piece can snap into various positions. The number located closest to the hand piece indicates the spot diameter on the skin in mm (spot sizes: 6/8/10/12/14 mm). The integrated hand piece detection feature automatically shows the selected spot diameter on the laser display. The parameter range is also automatically adjusted for the corresponding range. The MedArt 928 scanner for ARION consists of a scanner with a connected transmission system and a spacer with a 8, 9, 10 and 12 mm spot size. The spacer determines the spot diameter on the skin and therefore the parameter range of the configurable energy densities as well. The spacers are inserted into the scanner as shown below and must be inserted into the scanner up to the limit stop position. The spacers now automatically sets a spot diameter of 8, 9, 10, and 12 mm on the skin; this is also shown automatically on the laser display. The parameter range is also automatically adjusted for the corresponding range. For epidermal cooling can be a cooling device adapted to the handpiece / scanner.

The provided text is a 510(k) summary for the Wavelight Arion device. A 510(k) summary typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies against specific acceptance criteria.

Based on the provided document, here's what can be extracted and what is explicitly stated as not presented:

Acceptance Criteria and Device Performance (Not presented)

The document explicitly states: "6. Performance Data None presented." This means that acceptance criteria and reported device performance against those criteria are not included in this 510(k) summary. The submission relies on substantial equivalence to predicate devices, not on new performance data.

Therefore, the following table cannot be filled from the provided text:

Here's an analysis of the other requested information:

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

• Sample size: Not applicable/Not provided, as no performance data or test set is mentioned.
• Data provenance: Not applicable/Not provided.

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

• Not applicable/Not provided, as no test set or ground truth establishment is mentioned.

4. Adjudication method for the test set:

• Not applicable/Not provided, as no test set or adjudication is mentioned.

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 or reported. This device is a laser system for hair removal, not an AI-assisted diagnostic tool typically evaluated with MRMC studies.

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

• Not applicable. This is a physical medical device (laser system), not a software algorithm or AI model.

7. The type of ground truth used:

• Not applicable/Not provided, as no performance data or ground truth is mentioned. The submission is based on substantial equivalence.

8. The sample size for the training set:

• Not applicable/Not provided, as no machine learning model or training set is mentioned.

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

• Not applicable/Not provided, as no machine learning model or training set is mentioned.

In summary: The 510(k) submission for the Wavelight Arion device explicitly states "Performance Data None presented." This implies that the device achieved marketing clearance through demonstrating substantial equivalence to predicate devices rather than by submitting new clinical or performance data against specific acceptance criteria. Therefore, most of the requested information, which pertains to performance studies and data, is not available in the provided document.

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1. In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue. This includes the removal of tattoos and treatment of benign pigmented lesions.
2. In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.

The SINON is a 694 nm Ruby laser system which can be operated in two different modes. The quality-switch or Q-switch or QS Operating Mode is characterized by extremely short pulse widths (ns = 103s) and high peak power (MW = 106 W). The QS Operating Mode in the SINON is used for the removal of tattoos and treatment of pigmented lesions. The second mode is the Free-Running Operating Mode which is used for the removal of hair.

The provided document, K040433 for the WaveLight Laser Technologie, AG SINON laser system, does not contain information about acceptance criteria or a study proving the device meets them.

The document explicitly states "Performance Data None presented." in section 6. This means there are no details available within this submission regarding:

• Specific acceptance criteria for device performance.
• Any studies conducted to demonstrate the device meets such criteria.
• Sample sizes for test sets or their provenance.
• Information about experts, ground truth, or adjudication methods for any hypothetical test sets.
• Any multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Training set details or how their ground truth was established.

This 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices based on device description and intended use, rather than presenting detailed performance study data.

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1. For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
2. The MYDON C laser system is also indicated for the treatment of wrinkles.
3. The MYDON C is also indicated for the removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB).
4. The MYDON C laser system is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
5. The intended use of the integral cooling system in the MYDON C laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.

The MYDON C is a 1064 nm solid-state long-pulsed Nd: YAG laser system. The beam is directed to the treatment area by a transmission system which is connected to the laser device and consists of a multifunction hose system and a tightly connected hand unit. In the multifunction hose system both laser radiation carrying quartz fiber as well as the cooling and signal leads are contained. The MYDON C transmission system includes skin cooling integrated into the hand unit and cools the area of skin that the laser covers. When the applicator is placed against the skin, its shape and the integrated hand unit cooling system cool the treatment area before, during and after the application of the laser pulse, all in a single step.

The hand unit inserts allow for various treatment types and parameter ranges. MYDON C offers the 1.5 and 3 mm hand unit inserts specifically for the treatment of vascular lesions, the 5 mm hand unit insert for the treatment of both vascular lesions and wrinkles, the 7 mm and 10 mm hand unit inserts for hair removal.

The provided document is a 510(k) summary for the MYDON C laser system. It describes the device, its indications for use, and a comparison to predicate devices, ultimately stating "Performance Data None presented." Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria.

Here's an analysis of why each requested point cannot be addressed by the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document explicitly states "Performance Data None presented."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not present. No performance data or studies are 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): Not present. No ground truth establishment is detailed as there's no performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. No test set or adjudication method is mentioned.
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 present. The device mentioned is a laser system, not an AI or imaging diagnostic tool, and no clinical studies are presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This question is irrelevant as it's not an algorithm, but a physical laser device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present. No ground truth is discussed.
8. The sample size for the training set: Not present. No training set is mentioned as no performance study is detailed.
9. How the ground truth for the training set was established: Not present. No training set or ground truth establishment is detailed.

In summary, the provided 510(k) document for the MYDON C laser system does not include any performance data, clinical study details, acceptance criteria, or information related to expert review or ground truth establishment. The approval is based on substantial equivalence to predicate devices, rather than new clinical performance data from the applicant.

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