(16 days)
The GentleMAX Family of Laser Systems is indicated for temporary hair reduction. Stable longterm or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. On all skin types (Fitzpatrick I-VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias)
1064nm
The GentleMAX Family of Laser Systems is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
The Candela GentleMAX Family of Lasers contains two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 nm, respectively. The output of each laser head is optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths.
Each laser head contains the appropriate solid state laser rod and high intensity xenon flashlamps to excite the laser medium. The laser heads are water cooled with a self contained circulating water system that includes a water to air heat exchanger so the system can be fully air-cooled. The temperature of the laser heads are regulated by the circulation of distilled water at a controlled temperature.
A high voltage power supply is used to charge a storage capacitor which provides energy to the flashlamps. An IGBT (high voltage switch) is used to discharge the capacitor through the flashlamp. Each laser head has its own dedicated IGBT switch which is how the system controls which wavelength is produced. The resulting flash of the flashlamp excites the laser rod which causes emission of a pulse of laser energy.
The Candela GentleMAX Laser System delivers laser energy with various pulse durations from 0.25 milliseconds to 300 milliseconds. The output of this laser is delivered to the area of reamment by means of a lens coupled user replaceable optical fiber with a treatment her and are artacted to its distal end. A trigger switch (fingerswitch or footswitch) is used to control the delivery of laser pulses. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be delivered repetitively as long as the switch is depressed, at repetition rates up to 10 pulses per second (depending on the chosen pulse duration).
Energy from the laser is directed to the target area via optical fiber handpiece delivery system. The Dynamic Cooling Device provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 1.5, 3, 6, 8, 10, 12, 15 and 18 millimeters on the skin. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece.
A microprocessor based system controller is used to monitor and direct all system functions. Operators of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via a touch screen and display panel. The touch screen panel can also be used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
The GentleMAX Family of Laser Systems are designed with six major components:
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- High voltage power supply and modulator system
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- Optical laser head
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- Circulator system
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- Optical delivery system
- S. Software control system
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- Dynamic cooling device
The Candela GentleMAX Family of Laser Systems are equipped with safety interlock systems to protect patients and operators.
The Candela GentleMAX Family of Laser Systems is a medical device for dermatological treatments. The 510(k) summary indicates that the device has comparable performance to its predicate devices, but it does not contain a study or data that assesses its performance against specific acceptance criteria.
The provided document is a 510(k) premarket notification. For devices cleared through the 510(k) pathway, the primary mechanism for demonstrating safety and efficacy is to show substantial equivalence to a legally marketed predicate device. This typically involves demonstrating that the new device has similar intended uses, technological characteristics, and performs as safely and effectively as the predicate without raising new questions of safety or effectiveness. Often, comparison to predicate device specifications and existing performance data for predicate devices is used rather than new, extensive clinical studies with specified acceptance criteria as might be seen for a PMA (Premarket Approval) submission.
Therefore, many of the requested details about acceptance criteria, study methodologies, and ground truth establishment are not typically found in a 510(k) summary that relies on substantial equivalence.
Here's a breakdown of the information as it relates to your request, indicating where information is present or absent based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated as such in 510(k)) | Reported Device Performance (from 510(k) showing equivalence) |
|---|---|
| Intended Uses: | The Candela GentleMAX Family of Laser Systems has the same intended uses as the predicate devices. |
| - Temporary hair reduction (755nm) | Indicated for temporary hair reduction, stable long-term or permanent reduction of hair, on all skin types (Fitzpatrick I-VI) including tanned skin. |
| - Treatment of benign pigmented lesions (755nm) | Indicated for treatment of benign pigmented lesions. |
| - Treatment of wrinkles (755nm) | Indicated for treatment of wrinkles. |
| - Photocoagulation of dermatological vascular lesions (755nm) | Indicated for the photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). |
| - Removal of unwanted hair (1064nm) | Indicated for the removal of unwanted hair, stable long-term or permanent hair reduction, and treatment of PFB on all skin types (Fitzpatrick I-VI) including tanned skin. |
| - Photocoagulation and hemostasis of pigmented and vascular lesions (1064nm) | Indicated for photocoagulation and hemostasis of pigmented and vascular lesions (e.g., port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins). |
| - Coagulation and hemostasis of soft tissue (1064nm) | Indicated for coagulation and hemostasis of soft tissue. |
| - Treatment of benign pigmented lesions (1064nm) | Indicated for benign pigmented lesions (e.g., lentigos, solar lentigos, cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos). |
| - Reduction of red pigmentation in hypertrophic and keloid scars (1064nm) | Indicated for the reduction of red pigmentation in hypertrophic and keloid scars. |
| - Treatment of wrinkles (1064nm) | Indicated for treatment of wrinkles. |
| Operating Principles: | Utilizes similar operating principles to the predicate devices. |
| Key Design Aspects: | Matches key design aspects including similar spot size, the same wavelengths, and the same maximum delivered fluence as the predicate devices. |
| Safety and Performance Standards: | Conforms to the Laser Performance Standard (21 CFR 1040), IEC (EN) 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60825-1, and IEC 60601-2-22. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not describe a specific clinical "test set" with a sample size or data provenance because it relies on substantial equivalence to predicate devices, rather than new, independent clinical performance data. The "testing" section primarily refers to compliance with laser and electrical safety standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable or provided. The submission does not detail a study that required expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable or provided. There is no described test set requiring an adjudication method.
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
This information is not applicable or provided. The device is a laser system for dermatological treatments and not an AI-assisted diagnostic device, so an MRMC study with human readers/AI assistance is not relevant to this 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable or provided. The device is a physical laser system, not an algorithm.
7. The Type of Ground Truth Used
This information is not applicable or provided as there is no specific performance study against a ground truth described in the document. Substantial equivalence relies on comparing the device's characteristics and intended use to those of already approved predicate devices.
8. The Sample Size for the Training Set
This information is not applicable or provided. The device is a physical laser system, and the submission does not mention any machine learning or AI components that would require a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable or provided for the reasons stated in point 8.
§ 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.