(82 days)
755nm: The Candela 3630 Laser System is indicated for the temporary hair reduction. Stable long-term or permanent hair 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-IV) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles.
1064nm: The Candela 3630 Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicted 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, hemoangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Bening 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 3630 Laser System contains two separate laser heads (Alexandrite and Nd Y AG) which produce laser light outputs of 755 mm and 1064 nm. The outputs of each laser head are 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 mm, 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 3630 Laser System delivers laser energy with various pulse durations from 0.25 milliseconds to 300 milliseconds (See attached specification 9914-92-0400 for further details). The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached 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). A microprocessor based system controller is used to monitor and direct all system functions. Users 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 function and to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Candela 3630 Laser System supports spot sizes from 1.5 to 18 mm.
The provided document is a 510(k) summary for the Candela 3630 Laser System, which focuses on establishing substantial equivalence to previously cleared predicate devices. As such, it does not contain the detailed information requested regarding specific acceptance criteria and a study proving the device meets those criteria.
This type of submission relies on demonstrating that the new device has the same intended use and similar technological characteristics as legally marketed predicate devices, and therefore raises no new questions of safety or effectiveness.
Here's a breakdown of why the requested information cannot be fully provided from this document:
- Acceptance Criteria and Reported Device Performance: This document states the new device has "similar functional features (including power output, spot size, repetition rate, energy, and fluence)" to the predicate devices. However, it does not provide a table of specific acceptance criteria or reported performance metrics for the Candela 3630 Laser System itself against those criteria. It refers to a "specification 9914-92-0400 for further details" regarding pulse durations, but this document is not included.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): Since the submission is based on substantial equivalence to predicate devices rather than a de novo clinical study proving performance against new acceptance criteria, these details are not present. The document focuses on comparing the new device's features and intended use to existing devices, assuming that if the features are similar, the safety and effectiveness are also similar.
In summary, the document states that the Candela 3630 Laser System is substantially equivalent to predicate devices based on similarities in intended use, functional features, design aspects, and operational methods. It does not provide data from a specific study designed to prove the device meets pre-defined acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about study design, sample sizes, ground truth, or expert involvement as this information is not present in the provided 510(k) summary.
§ 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.