(154 days)
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)
- 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 entire laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of an articulated arm and a specially designed MultiSpot Handpiece (532 nm and 1064 nm) or optional Multilite Dye Laser Handpiece (650 nm and 585 nm). The user activates laser emission by means of a footswitch.
The RevLite Systems are designed to provide laser energy for use in a variety of dermatological procedures (see indications for use). The 532 nm and 1064 nm wavelengths and optional 650 nm and 585 nm wavelengths are absorbed by pigment and other chromophores within the skin to create the desired clinical effect. The laser incorporates very narrow laser pulses (5-20 ns) designed to apply higher peak power over a very short period to minimize the time to absorb heat into the tissue.
This 510(k) submission for the RevLite™ Q-Switched Nd:YAG Laser System is for a new indication for use and therefore does not include a study to prove acceptance criteria. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria.
The provided document describes the device, its intended use, and compares it to predicate devices. It states under "Nonclinical Performance Data" and "Clinical Performance Data" that "None" were requested or provided at the time of this submission. The FDA's letter (K083899) confirms that the device was deemed "substantially equivalent" for the stated indications based on comparison to predicate devices, not on new performance data demonstrating specific acceptance criteria.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I describe study details like sample sizes, ground truth establishment, or expert adjudication, as this information is not present in the provided document.
Summary of unavailable information based on the provided document:
- A table of acceptance criteria and the reported device performance: Not provided. The submission states "None" for clinical performance data.
- Sample sized used for the test set and the data provenance: Not applicable, as no new clinical study data was presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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 is a laser system, not an AI diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a laser system, not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.