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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 MedLite™ C1 Q-Switched Nd:YAG Laser is intended for: Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

Not Found

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the MedLite™ C1 Q-Switched Nd:YAG Laser, which focuses on demonstrating substantial equivalence to a predicate device rather than providing performance data against specific acceptance criteria.

The "Nonclinical Performance Data" and "Clinical Performance Data" sections both state "None," indicating that no specific performance studies were included in this submission to prove device performance against acceptance criteria.

Therefore, I cannot extract the requested information from the provided text.

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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 adjunct 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

For light activation for bleaching materials for teeth whitening For laser-assisted bleaching/whitening for teeth.

Not Found

The provided text is a 510(k) Summary for the DioDent II Dental Laser System. It explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None."

Therefore, based on the provided input:

1. A table of acceptance criteria and the reported device performance:
There are no acceptance criteria or reported device performance data provided in the document.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No sample size, test set, or data provenance information is provided as no clinical performance data was submitted.

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, as no clinical performance data was submitted, and therefore no ground truth establishment was described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical performance data was submitted.

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 device is a dental laser system, not an AI-assisted diagnostic tool. No comparative effectiveness study of this nature was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a dental laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no clinical performance data was submitted.

8. The sample size for the training set:
Not applicable, as no clinical performance data was submitted and this device is not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established:
Not applicable, as no clinical performance data was submitted and this device is not an AI/ML algorithm.

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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 adjunct to root canal therapy
Reduction of gingival hypertrophy
Soft tissue crown lengthening
Sulcular 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

For light activation for bleaching materials for teeth whitening
For laser-assisted bleaching/whitening for teeth.

Dental diode laser

The provided 510(k) summary for the LVI lase dental diode laser states that no clinical or non-clinical performance data was submitted.

Therefore, the device's acceptance criteria and the study proving it meets these criteria are not detailed in the provided text. The submission was likely based on demonstrating substantial equivalence to predicate devices, focusing on operating parameters, physical characteristics, and intended uses rather than novel performance claims requiring extensive new testing.

The document explicitly states:

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

Without specific studies mentioned, it's impossible to provide the requested details regarding:

1. A table of acceptance criteria and reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance
7. 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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Cutting, shaving, contouring and resection of oral osseous tissues (bone)

Not Found

This submission for the DELight Dental Laser System (K032797) contains no information on acceptance criteria or a study proving device performance against such criteria.

The 510(k) Summary explicitly states:

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

Therefore, I cannot provide the requested information. The device was cleared based on substantial equivalence to predicate devices (WaterLase, Millennium dental laser system) without new performance data being submitted or reviewed.

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