(86 days)
The Q-Switched Nd: YAG Laser Therapy System (1064nm or 532nm) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows:
1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota. 532mm: -Tattoo Removal Light ink: red. Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
The Q-Switched Nd:YAG Laser Systems is based on the Q-Switched Nd: YAG (1064 nm) and frequency doubled KTP Nd: YAG (532nm) Laser Technology. There is one optical cavity containing the Nd: YAG Crystal. It is composed of laser module, articulated arm, laser power supply, cooling system and display and control system.
The Q-Switched Nd: YAG Laser Therapy Systems works based on laser selective photothermy and blasting mechanism of Q-switched laser. Energy form particular wavelength with accurate dose will act on certain targeted color radicals: ink, carbon particles from derma and epidermis, exogenous pigment particles and endogenous melanophore from derma and epidermis. When suddenly being heated, pigment particles immediately blast into smaller pieces, which will be swallowed by macrophage phagocytosis and enters into lymph circulation system and finally be discharged out of body.
The physician is able to select the desired wavelength and the related output energy, spot size and fluency via control panel.
The provided document is a 510(k) summary for the Beijing Sincoheren Science And Technology Development Co.'s Q-Switched Nd:YAG Laser Therapy Systems. It aims to demonstrate substantial equivalence to a predicate device, not to establish new safety or effectiveness. Therefore, the document discusses performance data in the context of equivalence rather than proving acceptance criteria for a novel device.
The document does not describe specific acceptance criteria in the typical sense (e.g., minimum sensitivity, specificity, or accuracy) for a new clinical indication or a new type of device. Instead, it relies on demonstrating that the performance characteristics of the proposed device are comparable to or better than those of the predicate device, and that it complies with relevant safety standards.
Here's an analysis of the provided information based on your requested points, framed within the context of a 510(k) submission for substantial equivalence:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly that the proposed device performs at least as well as, or is sufficiently similar to, the predicate device in terms of technical specifications and safety. The reported device performance is presented as a comparison table against the predicate device.
| Specification | Predicate device performance | Proposed device performance | Comparison Discussion (Implicit Acceptance) |
|---|---|---|---|
| K number | K133158 | -- | (Predicate ID) |
| Product Code | GEX | GEX | Identical |
| Manufacturer | Beijing Toplaser Technology Co., Ltd | Beijing Sincoheren Science and Technology Development Co., Ltd. | (Different companies, but not a performance metric) |
| Device name | Nd: YAG Laser System | Q-Switched Nd: YAG Laser Therapy Systems | Similar |
| Indications for use | 1064nm: -Tattoo Removal (Dark ink: blue and black) -Treatment of Benign Pigmented Lesions (Nevus of ota) 532nm: -Tattoo Removal (Light ink: red; Light ink: sky blue and green) - Treatment of Benign Vascular Lesions (Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi) -Treatment of Benign Pigmented Lesions (Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.) | 1064nm: -Tattoo Removal (Dark ink: blue and black) -Treatment of Benign Pigmented Lesions (Nevus of ota) 532nm: -Tattoo Removal (Light ink: red; Light ink: sky blue and green) - Treatment of Benign Vascular Lesions (Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi) -Treatment of Benign Pigmented Lesions (Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.) | Identical (Demonstrates equivalence in intended use) |
| Technology | Q-Switched ND:YAG and KTP Nd: YAG Laser | Q -Switched ND:YAG and KTP Nd: YAG Laser | Identical |
| Energy Source | Xenon Lamp | Xenon Lamp | Identical |
| Wavelength (nm) | 1064nm and 532nm | 1064nm and 532nm | Identical |
| Aiming beam wavelength | 635nm | 635nm | Identical |
| Laser output mode | Q-switched pulse | Q-switched pulse | Identical |
| Aiming laser output power |
§ 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.