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The Medlite Q-Switched Laser System is indicated for use in dermatologic and general surgical procedures for coagulation and hemostasis.

The Medlite Q-Switched Laser System is indicated for use in laser skin resurfacing procedures for the treatment of acne scars and wrinkles.

The Medlite Q-Switched Laser is a laser device with a Nd:YAG laser medium, Q-Switched pulse method, Max Power of 30 Watts, Wavelength of 1064 & 532, Power Supply of 110/120 VAC - 50/60 Hz and 220/240 VAC - 50/60 Hz, Pulse Rate of 1, 2, 5, 10, Single Shot, Pulse Duration (nsec) of Less than 20, Beam Delivery via Handpiece using articulated arm, Multimode Beam Quality, and Microprocessor Control.

The provided document is a 510(k) premarket notification for the Medlite Q-Switched Laser. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study for meeting specific acceptance criteria in the context of diagnostics or AI performance. Therefore, detailed information typically found in clinical studies assessing device performance against acceptance criteria (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or types of ground truth) is not present in this document.

The "acceptance criteria" here are implicit in demonstrating substantial equivalence: the proposed device's features and indications for use must be similar enough to a predicate device.

Here's an attempt to extract relevant information given the limitations of the document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are not framed as performance metrics (e.g., sensitivity, specificity) but rather as a comparison of specifications and intended use against a predicate device. The "reported device performance" is essentially the listed specifications of the proposed device, which are shown to be identical or sufficiently similar to the predicate.

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

This document describes a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" of patient data. Therefore, there is no information on a clinical test set sample size or data provenance. The "test" here involves comparing device specifications.

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

Not applicable. "Ground truth" in the sense of clinical annotations by experts is not established for this type of submission. The "ground truth" for the comparison is the published specifications of the predicate devices.

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

Not applicable. There is no clinical test set requiring adjudication.

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 device, and no MRMC study was performed or reported.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" for this substantial equivalence claim is the technical specifications and indications for use of legally marketed predicate devices (K971207 and K983054). The comparison is based on documented features rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. No training set is involved.

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Light activation for bleaching materials for teeth whitening. Laser-assisted bleaching/whitening for teeth.

Not Found

The provided 510(k) summary for the DioDent Dental Laser System (K022351) explicitly states:

Clinical Performance Data: None.

Therefore, there is no information in the provided document about acceptance criteria or a study that proves the device meets any such criteria. This submission relies on substantial equivalence to predicate devices based on principles of operation, function, and intended use, rather than on clinical performance data.

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• Tooth preparation to obtain access to the root canal
• Pulpotomy
• Pulp extirpation
• Pulpotomy as an adjunct to root canal therapy
• Root canal debridement and cleaning
• Root canal preparation including enlargement

Not Found

The provided 510(k) summary for the DELight dental laser system does not contain information related to acceptance criteria or a study proving the device meets such criteria.

The summary explicitly states:

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

This submission relies on substantial equivalence to predicate devices (WaterLase, Millennium dental laser system) without presenting new performance data. Therefore, I cannot fulfill the request to provide the table of acceptance criteria, reported device performance, or details about any study, as no such information is present in the provided text.

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The DioDent Dental Laser System is intended for incision, excision, ablation, vaporization and/or coagulation of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva).
For the incision, excision, ablation, vaporization and hemostasis of oral soft tissue. Examples: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunt to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Sucular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) Treatment of aphthous ulcers Vestibuloplasty Biopsy incision and excision Lesion (tumor) removal

Not Found

The provided document is a 510(k) summary for the DioDent Dental Laser System. It states that no nonclinical or clinical performance data was provided or used to establish the substantial equivalence of the device.

Therefore, I cannot provide information on acceptance criteria and the study that proves the device meets those criteria, as no such study was presented in this submission. The device was deemed substantially equivalent to predicate devices based on its operating parameters, physical characteristics, and intended uses without requiring new performance data.

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Tattoo Removal

• dark ink: blue and black
• light ink: red
• light ink: sky blue
• light ink: green

Treatment of Vascular Lesions

• port wine birthmarks
• telangiectasias
• spider angioma
• cherry angioma
• spider nevi

Treatment of Pigmented Lesions

• cafe-au-lait birthmarks
• solar lentiginos
• senile lentiginos
• becker's nevi
• freckles
• nevus spilus
• nevus of ota

Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

Removal or lightening of unwanted hair with or without adjuvant preparation

Medlite C6 Q-Switched Nd:YAG Laser

The provided text is a 510(k) summary for the Medlite C6 Q-Switched Nd:YAG Laser. It explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None". This means there are no acceptance criteria or studies presented within this document to demonstrate the device meets any specific performance metrics.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are reported.
2. Sample sized used for the test set and the data provenance: No test set information is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method for the test set: No test set or adjudication method 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: No such study is mentioned; this 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: Not applicable for this type of device.
7. The type of ground truth used: No ground truth is mentioned.
8. The sample size for the training set: Not applicable for this type of device.
9. How the ground truth for the training set was established: Not applicable for this type of device.

Conclusion:

The Medlite C6 Q-Switched Nd:YAG Laser received 510(k) clearance based on its substantial equivalence to predicate devices (Medlite™ IV, Medlite™ C3 Q-Switched Nd:YAG Lasers). The application explicitly states that no nonclinical or clinical performance data was submitted to demonstrate meeting specific acceptance criteria through a study. This implies that its safety and effectiveness were deemed acceptable based on the established performance and regulatory history of the equivalent predicate devices.

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• Tattoo Removal
• Treatment of Vascular Lesions
• Treatment of Pigmented Lesions
• Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

The MedliteTM C3 Q-Switched Nd:YAG Laser bases its design/construction from the integration of primary subsystems extracted from legally marketed predicate Continuum products. The new device performs and is specified within all product parameters of the predicate devices.

The provided 510(k) summary for the Medlite™ C3 Q-Switched Nd:YAG Laser explicitly states "None" for both "Nonclinical Performance Data" and "Clinical Performance Data".

Therefore, no information is available within this document to answer the requested questions regarding acceptance criteria and a study demonstrating the device meets those criteria. The device was found substantially equivalent to predicate devices based on its design/construction and performance within product parameters of those predicates, not on new performance data.

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