Q Switched Nd:YAG Laser machine (QNHF-01)

The Q Switched Nd:YAG Laser machine (QNHF-01) is a laser surgical instrument indicated for tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, and incision, excision, ablation, and vaporization of soft tissue in general dermatology. It delivers laser energy at wavelengths of 1064 nm (for dark inks and pigmented lesions) or 532 nm (for light inks, vascular lesions, and pigmented lesions), with output energy selectable by the physician via a control panel.

Both the proposed device and predicate have output wavelengths of 1064 nm and 532 nm with treatment window diameter ranges of 2–10 mm. The proposed device has a pulsewidth of 6 nanoseconds (versus 5 ns for the predicate), a maximum repetition rate of 10 Hz (versus 5 Hz for the predicate), and a maximum 532 nm pulse energy of 260 mJ (versus 250 mJ for the predicate). The device consists of a control panel module, main control module, laser power module, temperature and humidity control module, and laser module.

IEC 60601-1 Edition 3.2 (general safety and performance), IEC 60601-1-2 Edition 4.1 (electromagnetic compatibility), IEC 60601-2-22 Edition 3.1 (surgical laser equipment), IEC 60825-1 Edition 2.0 (laser safety), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and hypersensitivity), and ISO 10993-23 (irritation tests).

The device is substantially equivalent because it has the same indications for use as the predicate device K163123 and shares the same output wavelengths and treatment window ranges. Although the proposed device has minor differences in pulsewidth (1 ns greater), repetition rate (5 Hz greater), and maximum 532 nm pulse energy (10 mJ greater), these differences do not raise new safety or efficacy questions. Non-clinical testing confirmed compliance with relevant medical device standards, and no clinical study was needed because the technological similarities and performance data support substantial equivalence.