(90 days)
The ParaScan Scanning Device and CBH-1 Collimated Beam Handpiece are intended for soft tissue indications (CO, soft tissue clearances previously obtained by Heraeus Surgical). In addition, indications include treatment of wrinkles/rhytides; solar/actinic elastosis; lentigos; laser skin resurfacing; laser resurfacing; laserbrasion; scar revision; warts; periorbital syringomas; epidermal nevi; rhinophyma; xanthelasma; actinic cheilitis and debulking benign tumors.
- ParaScan™ Scanning Device A.
- CBH-1 Collimated Beam Handpiece B.
This document does not contain information about acceptance criteria or a study proving a device meets them. The provided text is a summary of safety and effectiveness for a medical device called ParaScan Scanning Device or CBH-1 Collimated Beam Handpiece, focusing on its regulatory classification, indications for use, and comparison with a predicate device. It does not include details about device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.
§ 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.