(30 days)
The Angelite Family of Intense Pulsed Light Systems (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, various benign pigmented lesions and hair removal as follow:
- Intense Pulse Light Energy Wavelengths from 400 950 nm are indicated for the treatment of inflammatory acne.
- Intense Pulse Light Energy Wavelengths from 560 1200 nm are indicated for the treatment of benign pigmented (epidermal and coetaneous) lesions including warts, scars and striae. For the treatment of benign (cutaneous) vascular lesions includes port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melagenna, angiomas and spider anglormas, poikiloderma of civatte, leg veins, facial veins and venous malformations.
- Intense Pulse Light Energy Wavelengths from 700 1200 nm are indicated for the treatment of unwanted hair (i.e., hair removal).
Angelite Family of Intense Pulsed Light Systems
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Angelite Family of Intense Pulsed Light Systems," indicating its substantial equivalence to a legally marketed predicate device.
The document includes:
- The device name and regulatory information.
- Indications for Use.
- Basic FDA contact and regulatory compliance information.
It does not contain:
- Specific acceptance criteria for the device's performance.
- Details of any study (like sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results) that would demonstrate the device meets acceptance criteria.
The information provided confirms that the device is cleared for market based on substantial equivalence, but it does not elaborate on the specific performance metrics or studies used to establish that equivalence beyond listing the indications for use.
§ 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.