(188 days)
Intended Use: PRIMELASE Excellence is intended for use in dermatologic and general surgical procedures.
Indications for Use:
PRIMELASE Excellence System with 810nm Laser applicator is intended for:
· Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
- · Treatment of Pseudofolliculitis barbae (PFB).
- · Use on all skin types (Fitzpatrick I-VI).
- · Treatment of benign pigmented lesions
PRIMELASE Excellence System with 755nm Laser applicator is intended for:
· Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
- · Treatment of Pseudofolliculitis barbae (PFB).
- · Use on all skin types (Fitzpatrick I-VI).
- · Treatment of benign pigmented lesions
PRIMELASE Excellence System with 1060nm Laser applicator is intended for:
· Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
- Treatment of Pseudofolliculitis barbae (PFB).
- · Use on all skin types (Fitzpatrick I-VI).
· Treatment of benign vascular lesions, including angiomas, telangiectasia, and other benign vascular lesions and leg veins.
- Treatment of wrinkles
PRIMELASE Excellence System with 810-1060nm Laser applicator is intended for:
· Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
- Treatment of Pseudofolliculitis barbae (PFB).
· Use on all skin types (Fitzpatrick I-VI).
PRIMELASE Excellence is a diode laser device which consists of a central unit and external applicators.
The PRIMELASE equipment emits laser radiation (beam infrared light with a wavelength range of 755 nm to 1060 nm, typically and most used 810 nm.), pulsed through the laser aperture situated at the tip of the applicator.
The device applicator contains the diode which emits the laser energy whereas the power delivered, and the working frequency being controlled by the machine's central unit.
The emission of energy is activated in the form of continuous pulses when pressing the applicator button. The applicator sapphire tip is cooled to a constant temperature to cool the skin, so that it partially anaesthetizes the tissue reducing the risk of damage to the epidermis during treatment.
The provided text does not contain information about acceptance criteria and a study that proves the device meets them in the format requested.
The document is a 510(k) premarket notification for the "Primelase Excellence" laser device. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting acceptance criteria and a study proving their fulfillment as typically seen for novel devices or significant modifications.
Here's a breakdown of why the requested information is not available in the provided text:
-
Acceptance Criteria and Reported Device Performance Table: The document provides a "Comparison of Technological Characteristics" table (Table 2) comparing the subject device to predicate devices. This table lists technical specifications (e.g., wavelength, spot size, fluence) but does not present specific acceptance criteria (e.g., a minimum percentage of hair reduction) or reported device performance against such criteria. Instead, it aims to show the subject device's specifications are comparable to those of already cleared devices.
-
Sample Size, Data Provenance, Expert Qualifications, Adjudication Method, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size, and Training Set Ground Truth: All these items are related to a clinical study and its methodology. The document explicitly states: "No clinical study is included in this submission." Therefore, none of this information is present. The substantial equivalence argument relies on the similarity of the device's technological characteristics and intended use to predicate devices for which efficacy and safety were established.
In summary, the document demonstrates substantial equivalence through technical comparisons and adherence to recognized standards for safety and performance (non-clinical testing), rather than through a dedicated clinical study with specific acceptance criteria and performance metrics.
§ 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.