(29 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)
- Dermal Pigmented Lesions
- 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 RevLite Q-Switched Nd:YAG Laser System with Handpiece Adaptor consists of a electrically powered Console in which laser energy produced within the system is delivered to the tissue by means of an articulated arm, Handpiece Adaptor and specially designed Handpieces. The user activates laser emission by means of a footswitch.
The provided 510(k) Premarket Notification for the Handpiece Adaptor RevLite Q-Switched Nd:YAG Laser System does not contain any information about acceptance criteria or a study proving the device meets said criteria.
Instead, the document focuses on establishing substantial equivalence to a predicate device (RevLite Q-Switched Nd:YAG Laser System with LCD, K083899). The key statement regarding performance is:
"The RevLite Q-Switched Nd:YAG Laser System with Handpiece Adaptor is comparable to its parent predicate device (RevLite Q-Switched Nd:YAG Laser System with LCD) in terms of its intended use, indications for use, technical specifications, operating performance features, and general design features."
Furthermore, it explicitly states:
- Nonclinical Performance Data: None
- Clinical Performance Data: None
This means that the submission relies entirely on the established safety and effectiveness of the predicate device, arguing that the new Handpiece Adaptor does not change the fundamental performance characteristics of the laser system. Therefore, I cannot extract the requested information as it is not present in the provided text.
§ 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.