(220 days)
Intense Pulsed Light (IPL-sq):
- Treatment mild to moderated inflammatory and pustular inflammatory acne vulgaris.
- The treatment of benign pigmented epidermal lesions including dyschromias, hyperpigmentation, melasma and ephelides (freckles).
- Lentigines, nevi, and café-au-lait macules.
- The treatment of cutaneous lesions including warts, scars and striae.
- The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, and venous malformations.
- The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent hair reduction.
Infrared (Intense IR):
Topical heating for the purpose of elevating tissue's temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase of local circulation where applied, and the relaxation of muscles. In addition, may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Laser Nd:Yag 1064nm (1064 LongPulse):
- Coagulation and hemostasis of vascular lesions and epidermal tissue, including the treatment of superficial and deep telangiectasias, reticular veins (0,1- 4 mm diameter) of the leg, rosacea, warts, venous lake, leg veins, poikiloderma of Civatte, angiomas, hemangiomas, and nevus;
- Non ablative treatment of facial wrinkles, scars and striae;
- The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent hair reduction;
- Treatment of pseudofolliculitis barbae.
Not Found
The provided text is a 510(k) summary for a medical device called "Etherea," but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
A 510(k) submission typically demonstrates substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in the way a clinical trial might. The document lists the indications for use of the Etherea device, which uses Intense Pulsed Light (IPL-sq) and Laser Nd:Yag 1064nm (1064 LongPulse) technologies for various dermatological and cosmetic treatments.
To answer your request, I would need a document specifically detailing performance studies and acceptance criteria for this device. The current document is a regulatory clearance letter and an "Indications for Use" statement.
§ 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.