(84 days)
The CO2 Laser Therapy Machine is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
The CO2 Laser Therapy Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
The CO2 Laser Therapy Machine is a carbon dioxide laser used in medical and aesthetic industry for treatment of such skin conditions as fine and coarse wrinkles, scars of various origin, uneven pigmentation and dilated pores. Due to the CO2 laser's high absorption of water, its high-energy beam of laser light interacts with the skin's surface causing the upper layer to peel off and use photothermolysis to stimulate deep cell regeneration and then achieve the target of skin improvement.
The proposed device is mainly used for human tissue vaporization, carbonization, coagulation and exposure to achieve the purpose of treatment.
The CO2 Laser Therapy Machine includes three models in this submission, FG 900, FG 900-B and FG 900-C, all three models have same principle, software, operation etc., only differences are appearance.
The proposed device includes the following components: Surgery tip, Surgery tip Arm, Touchscreen, Emergency Switch, Key Switch, Goggles for Patient, Goggles for Doctor, Foot Switch.
The provided document is a 510(k) Summary for a CO2 Laser Therapy Machine. It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison of the proposed device against a predicate device across various parameters. It doesn't explicitly state "acceptance criteria" for each parameter with numeric thresholds, but rather lists characteristics that are considered "Substantially Equivalent (SE)" if they match or are comparable to the predicate. The performance is reported as the proposed device's specifications.
| Parameter | Acceptance Criteria (Implied by Predicate) | Reported Device Performance | Remark (as per document) |
|---|---|---|---|
| Product Code | GEX | GEX | SE |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | 2 | 2 | SE |
| Where used | Hospital | Hospital | SE |
| Intended Use | Human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | Human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | SE |
| Maximum Power | CFL-10: 12W (±20%), UFL-60: 30W (±20%) | 30W | SE |
| Work Mode | Scanner (half, fast and random), Surgery (CW, repeat and pulse) | Surgery (Single Pulse, Continuous, Muti-Pulse) | SE |
| Wavelength | 10.6 um | 10.6 um | SE |
| Mode Structure | TEM00 | TEM00 | SE |
| Beam Delivery | 7 knucklearmkey joints light arm | 7 knucklearmkey joints light arm | SE |
| Light Arm | CFL-10: 0.97m, UFL-60: 1.17m | 1.32m | Analysis |
| Aiming Beam | 650nm red diode laser ( |
§ 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.