NOABLE LASER

The NOABLE LASER is a 1450nm diode laser surgical instrument for dermatological use, including incision, excision, ablation, and vaporization of soft tissue with hemostasis. It is indicated for treating back acne, atrophic acne scars, facial wrinkles, mild to moderate acne vulgaris, and sebaceous hyperplasia. The device includes a dynamic cooling device (cryogen spray) to protect skin and reduce irritation during laser treatment.

The proposed device uses a 1450nm diode laser with 1450nm ± 10% wavelength and 635nm ± 10% pointing beam, similar to the predicate A-Fit device. Key differences include: activation via both footswitch and hand-piece switch (versus footswitch only); cooling duration of 25-50ms versus 10-50ms; and different electrical requirements (100-240VAC versus 110V 60Hz). Maximum laser output ranges from 4-12 J/cm² in stamping mode and 4-8 J/cm² in toning mode, with beam sizes of 4mm or 6mm.

IEC 60601-1:2005+A2:2020 (medical electrical equipment general requirements), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), IEC 60601-2-22:2019 (surgical laser equipment requirements), IEC 60825-1:2014 (laser safety), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), and ISO 10993-23:2021 (irritation testing).

The device is substantially equivalent because it uses identical laser technology (1450nm diode laser), identical indications for use, and the same beam delivery and cooling system principles as the predicate A-Fit device. Minor differences in activation method, cooling duration, and electrical specifications do not affect safety or effectiveness, as confirmed by the device passing all required electrical safety, EMC, and biocompatibility standards. The device's performance parameters (energy output, pulse duration, beam size) are within or comparable to the predicate device's specifications.