(180 days)
Incision, excision, ablation, vaporization of soft tissue for general dermatology.
Removal or lightening of unwanted hair with or without adjuvant preparation.
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:
- café-au-lait birthmarks .
- solar lentiginos .
- senile lentiginos .
- becker's nevi
- freckles
- nevus spilus
- nevus of ota
The Helios II® laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. Three basic elements of operations are as follows:
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A Nd:YAG crystal is used as a gain medium which produces a laser beam.
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A resonator then amplifies the beam.
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A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy. This converted light energy pumps the Nd:YAG crystal - a gain medium - and the light exhausted from the crystal is amplified into a specific wavelength light. As it passes between the resonant gases, laser beam radiates to an output unit.
The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.
The provided text is a 510(k) summary for the Helios II® Q-Switched Nd:YAG Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria through performance data.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies are not available in the provided document.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria with corresponding device performance metrics. Instead, it states that the device "share very similar / exactly same performance specification parameters" as its predicate devices, implying that the performance of the predicate devices implicitly sets the "acceptance criteria."
| Acceptance Criteria (Implied from Predicate Equivalence) | Reported Device Performance |
|---|---|
| Performance specifications of Fotona QX Nd:VAG/KTP Laser System (K053139) | "very similar / exactly same performance specification parameters" to predicate devices |
| Performance specifications of Medlite C3 Q Switched Nd:YAG Laser (K011677) | "very similar / exactly same performance specification parameters" to predicate devices |
| Performance specifications of Medlite C6 Q Switched Nd:YAG Laser (K014234) | "very similar / exactly same performance specification parameters" to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample size for the test set: Not provided. The document does not describe a specific "test set" in the context of performance evaluation with discrete metrics.
- Data Provenance: Not applicable, as no specific performance study with a test set is described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. No ground truth establishment for a test set is described.
4. Adjudication Method for the Test Set:
- Not applicable. No adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The document states "None" under "Performance Data" except for the conclusion about substantial equivalence. This type of study would involve human readers and AI performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laser system, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance data section doesn't detail any standalone performance tests for the laser beyond the claim of substantial equivalence.
7. The Type of Ground Truth Used:
- Not applicable. No ground truth is described in the context of a performance study. The approval is based on substantial equivalence to predicate devices, which implies that the predicate devices' established safety and effectiveness serve as the "ground truth" for demonstrating equivalence.
8. The Sample Size for the Training Set:
- Not applicable. This device is a laser system, not an AI algorithm or a device requiring a "training set" in the typical sense of machine learning.
9. How the Ground Truth for the Training Set was Established:
- Not applicable for the same reasons as above.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.