(73 days)
The Q-MASTER Q-Switched Nd:YAG Laser System is indicated for incision, ablation and vaporization of soft tissue for general dermatology.
1064nm wavelength in Q-switched mode:
- Removal of dark ink (black, blue and brown) tattoos
- Treatment of nevus of Ota
- Treatment of common nevus
- Removal or lightening of unwanted hair
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
1064nm wavelength in non Q-switched mode:
- Removal of unwanted hair, for stable long term, reduced hair growth when measured at 6, 9 and 12 months and for treatment of PFB (Pseudo Folliculitis Barbae). The laser is indicated for all skin types including tanned skin
- Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not linited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins
- Coagulation and hemostasis of soft tissue
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris
532nm wavelength in Q-switched mode (nominal delivered energy of 585nm and 650mm with the optional 585nm and 650nm dye hand-piece):
- Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
- Treatment of benign vascular lesions including, but not limited to:
- port wine birthmarks
- telangiectasias
- spider angioma
- cherry angioma
- spider nevus
- Treatment of benign pigmented lesions including, but not limited to:
- café-au-lait birthmarks
- solar lentigines
- senile lentigines
- Becker's nevus
- freckles
- common nevus
- nevus spilus
- Treatment of seborrheic keratosis
- Treatment of post inflammatory hyperpigmentation
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
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This document is a 510(k) clearance letter for the Q-MASTER Q-Switched Nd:YAG Laser System. It does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting specific performance metrics against pre-defined acceptance criteria in the format requested. The document lists the indications for use for the device, but it does not include a clinical study design, results, or acceptance criteria.
Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study proving device performance based on 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.