(303 days)
The Affirm CO2 and Affirm CO2 HP lasers are indicated for incision, excision, and coagulation of body soft tissue.
The Affirm CO2 and Affirm CO2 HP lasers with SmartScan scanner are indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissue including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental, and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Affirm CO2 and Affirm CO2 HP lasers are CO2 laser, having CO2 gas as the lasing medium. It is a laser with a wavelength of 10.6 µm. Laser activation is by foot switch. Overall weight of the laser is 25 Kg, and the size is 180x62x42 cm (HxWxD). Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase.
The provided document is a 510(k) summary for the Affirm CO2 and Affirm CO2 HP lasers. This type of regulatory submission states that the device is substantially equivalent to legally marketed predicate devices and generally does not involve extensive clinical trials with acceptance criteria, sample sizes, or ground truth establishment in the same way an AI/ML medical device submission would.
Based on the provided text, there are no acceptance criteria or a study that proves the device meets them because the submission states "Nonclinical Performance Data: none" and "Clinical Performance Data: none".
Therefore, I cannot provide the requested information in the format of acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as these elements are explicitly stated as absent in the provided document.
The document concludes that the device is safe and effective based on its substantial equivalence to predicate devices (Smart CO2 laser and SmartXide CO2 with DOT Scanner laser), which have the same principle of operation, wavelength, and power range for the same indications for use.
Summary of what can be extracted from the document:
- Device Trade Name: Affirm CO2 and Affirm CO2 HP lasers
- Intended Use: Incision, excision, and coagulation of body soft tissue. (Expanded in the Indications for Use on page 3 to include ablation, vaporization, and coagulation of body soft tissue including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental, oral surgery, and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.)
- Basis for Clearance: Substantial equivalence to predicate devices (Smart CO2 laser and SmartXide CO2 with DOT Scanner laser) based on similar principle of operation, wavelength, and power range.
- Nonclinical Performance Data: None provided.
- Clinical Performance Data: None provided.
§ 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.